SOPs

Micro-dose Dilution Technique for the low API content products

SOPs

Micro-dose Dilution Technique, Purpose:

Micro-dose Dilution Technique, To ensure the confirmation of content uniformity of the lower quantity of Active Pharmaceuticals Ingredient (lower than 10 mg per unit) presents in the selective products of the XX pharmaceuticals Limited.

Micro-dose Dilution Technique, Scope:

This SOP is applicable for the selective products (API content less tha10 mg per unit) processes at the
Production Unit of the XX Pharmaceuticals Limited.

Definitions / Abbreviation:

[][]Micro-Dose: Smaller quantity with respect to the Processing Batch Size.
[][]BMR: Batch Manufacturing Record.

Responsibilities:

[][]The Roles and Responsibilities are as follows:

Machine Operator

[][]To follow the laid down procedure.

Executive, Product Development

[][]To establish the steps of dilution as parts of total mixing

Executive, Production

[][]To monitor the steps of dilution as parts with described timeline throughout the Mixing Process.

Manager, Production

[][]To implement this correctly.

Manager, Quality Assurance

[][]To approve the Document.

Annexure:

N/A.

Procedures:

Precautions:

[][]To check all the Materials for the involved batch must be available at the beginning of the process.
[][]First sort out the Active Pharmaceutical Ingredient (API) and excipients from the supplied batch materials.
[][]Divide the API(s) to make them three parts.
[][]First step
[][]Take one third of API (1st part of API) and equal quantity of excipients in a poly bag.
[][]Mix them for 3-5 minutes.(premix-1)
[][]Take premix-1 and equal quantity of excipients (Filler) in the poly bag.
[][]Mix them for 3-5 minutes. (premix-2)
[][]Take premix-2 and equal quantity of excipients (Filler) in the poly bag.
[][]Mix them for 3-5 minutes. (premix-3)
[][]Second Step: Repeat the same process  for the second part of API
[][]Third Step: Repeat the same process for the third part of API
[][]Mix first, second and third part of premix respectively for 2-3 minutes clockwise manually.
[][]Calculate the active premix from step  into two part A & B.
[][]Take the remaining excipients of batch quantity and pass through Vibratory Sifter or manually sieve.
[][]Then take part A of active premix into Vibratory Sifter.
[][]Take the remaining excipients of 2nd part  & pass through Vibratory Sifter or manually sieve.
[][]Then take part B and pass through the Vibratory Sifter or manually sieve.
[][]Now take all the parts to the Cone Blender.
[][]Seal the Cone Blender with its upper part & start dry mixing all the parts as a whole for up to 30 minutes.
[][]Stop the Cone Blender and allow the In-Process Quality Compliance (IPQC) Person to take the required quantity of sample for checking the content uniformity of the Micro-Dose API as of the calculation basis.
[][]If the IPQC person declares the dry mixing status satisfactory, then start the next process as mentioned in the BMR.
[][]If the dry mixing status found unsatisfactory, then go for Cone Blender operation for another 15 minutes. Then follow  as mentioned above satisfactory for the next process.
[][]Proceed for next operation as per the BMR.

Micro-dose Dilution Technique for the low API content products Read More »

Line Clearance at Production Area

Production, SOPs

Line Clearance , Purpose:

Line Clearance , To lay down the procedure for Line Clearance at Production Area during Product to Product changeover and Batch to Batch changeover.

Line Clearance , Scope:

This SOP is applicable for the Production Area of XX Pharmaceuticals Limited.

Definitions / Abbreviation:

N/A.

Responsibilities:

[][]The Roles and Responsibilities are as follows:

Operator

[][]To follow the laid down procedure.

Executive, Production

[][]To monitor and check the laid down procedure.

Manager, Production

[][]To implement this correctly

Manager, Quality Assurance

[][]To approve the Document.

Procedure:

Precautions:

[][]Ensure the proper safety instructions are followed.
[][]Ensure that no previous product is available in the area.

Line Clearance during Product to Product Changeover

[][]Ensure that all utility lines like compressed air line, steam line, electrical fixtures, air inlet ducts, return air risers, potable water and purified water lines are cleaned and no visible traces of product are present.
[][]Ensure that door, floor, walls and ceiling are cleaned.
[][]Ensure that area cleaning activity is recorded in ‘Room Cleaning Log book’
[][]Ensure that all equipments in the area are cleaned according to their respective SOPs and no traces of previous product are visible within the equipment.
[][]Check and ensure that equipment cleaning activity is recorded in respective ‘Equipment Log Book’
[][]Ensure that Span between equipment usage and cleaning is not more than seventy two hours.
[][]Ensure that Balances in the production area are cleaned and accuracy check is done once daily.
[][]Ensure that production utensils like scoops, spatula, pallets, BMR table, tool boxes etc. are cleaned as per procedure.
[][]Ensure that all equipments are labeled as ‘CLEANED’
[][]Ensure that fresh set of gowns are issued to concerned operators.
[][]Ensure that proper environmental condition is maintained in the area and the records of the same are maintained in the specified formats.
[][]Ensure the correctness of Batch Manufacturing Record / Batch Packaging Record.

Line Clearance during Batch to Batch Changeover

[][]Ensure that previous batch material is removed from the production area.
[][]Ensure that all the equipment and their spares are cleaned according to their respective SOPs.
[][]Ensure that equipment cleaning activity is recorded in respective ‘Equipment Log Book’.
[][]Ensure that floor is cleaned using vacuum cleaner and no visible traces of the previous batch material on the floor.

Annexure:

[][]N/A

Line Clearance at Production Area Read More »

Raw & Primary Packaging Materials Dispensing

SOPs

Raw & Primary Packaging Materials, Purpose:

Raw & Primary Packaging Materials, To lay down the procedure for Dispensing of Raw and Primary Packaging Materials used for Manufacturing of Products.

Raw & Primary Packaging Materials, Scope:

This SOP is applicable for the Production Area of General Block of the XX Pharmaceuticals Limited.

Definitions / Abbreviation:

Dispensing: To Prepare and Distribute Medicine.

Responsibilities:

[][]The Roles and Responsibilities are as follows :

Operator

[][]To follow the laid down procedure

Executive, Production

[][]To monitor and check the laid down procedure.

Manager, Production

[][]To implement this correctly

Manager, Quality Assurance

[][]To approve the Document

Annexure:

[][]N/A.

Procedure:

Precautions:

[][]Ensure the cleanliness of Dispensing Area, Weighing Balances, Dispensing Booth, Waste Bin, Pallets before commencing the dispensing activity.
[][]Ensure that Balances are Calibrated and checked for daily accuracy.
[][]Ensure that Dispensing Booth should be switched ‘ON’ 30 minutes before starting dispensing activity.
[][]Ensure that Pressure Differential, Temperature and Relative Humidity of Raw Material (RM) Store, Dispensing and Post Dispensing area are within the specified range. Record details of the same in specified log books.
[][]Executive, Production should obtain Line Clearance from Executive, In-Process Quality Control(IPQC) before dispensing of Batch.
[][]Use separate scoop / spoon for Active Pharmaceutical Ingredient (API) & excipients.
[][]Use hand gloves, mask and eye protector (if required) during weighing and handling of materials.

Dispensing of Raw & Primary Packaging Materials:

[][]Production Personnel shall send the Bill of Material (BOM) along with Batch Manufacturing Record & Batch Packaging Record of respective batch / batches of Product to dispensing unit for dispensing of Raw & Primary Packaging Materials 24 hours in advance.
[][]Upon receipt of BOM Production Personnel shall calculate the quantity of active material for a batch on the basis of potency and other excipient as required.

[][]Operator shall arrange to transfer the required materials from RM & PM Store to ‘Material Staging’ through Air lock corridor.

Material Entry to Dispensing Booth:

[][]Dispensing operator will bring raw materials from ‘Material Staging Area’ to Dispensing Booth through material entry one by one.
[][]Only one raw material shall be dispensed at a time.
[][]Excipients shall be dispensed first and then Active Pharmaceuticals Ingredients (API).

Man Entry to Dispensing Booth:

[][]Dispensing execution team, Executive Quality Compliance, Executive Production and Production Operator will enter in the Dispensing booth through man entry with proper gowning.
[][]Operator shall take the required number of clean and dried Stainless Steel (SS) Scoops/Spatula/ Spoon for dispensing of materials.

Dispensing of Raw Materials :

[][]Obtain Line Clearance approval from Executive, Quality Compliance before starting the dispensing activity.
[][]Operator shall check status labels affixed on the container & simultaneously checked by Executive, Production and Executive, Quality Compliance.
[][]Keep the clean container/drum & polybag in the room.
[][]Fresh double polybags shall be used for holding dispensed materials.
[][]In case of spillage of any raw material during dispensing, collect and weigh the quantity of spillage and destroy.
[][]During weighing of each material, ensure zero on weighing scale before proceeding for dispensing.
[][]Weight the empty Polybag and tare the weight by pressing ‘Tare’ button. Then record in ‘MATERIAL DISPENSING SLIP’

[][]Loose container/ bag should be taken first for dispensing.
[][]Transfer the required quantity of material into tare polybag as per BOM and record the weight in ‘MATERIAL DISPENSING SLIP’.
[][]Remove the issued material of polybag from the weighing balance and keep them on the respective material holding SS Cage Trolley.
[][]After completion of weighing of all materials transfer into the ‘Dispensed Material Staging’ Area & keep the room locked.
[][]In case any quantity of the material is left in original container / bag, affix ‘LOOSE LABEL’  on container/bag.
[][]Keep the Loose bags or containers in ‘Broken Bulk’ room. Send back them to RM Store through Airlock corridor except active material.
[][]At the time of Dispensing, Operator shall fill the details of each dispensed material in the BOM and simultaneously cross checked by Executive, Production and Executive, Quality Compliance.
[][]Dispensing operator shall prepare ‘MATERIAL DISPENSING SLIP’ for each dispensed Materials and which shall be simultaneously checked by Executive, Production and verified by Executive, QA.
[][]Operator shall sign in the column marked as ‘Dispensed by’ in BOM after issue of each and every raw material at the time of dispensing.
[][]Executive, Production shall sign in the column marked as ‘Checked by’ in BOM against each and every raw material.
[][]Executive, Quality Compliance shall sign in the column marked as ‘Checked by’ in BOM against each and every raw material.
[][]In case of any adverse observation, report to Executive, In-Process Quality Compliance (IPQC) for corrective action.
[][]Deface all the labels of empty containers / polybags / boxes / plastic tie with cross marking and transfer them to the scrap area through designated route.

[][]On completion of Dispensing, clean the dispensing area, booth, balances, and utensils as per respective cleaning procedures & record the same in log book. Hang the status label ‘CLEANED’  outside the door.

Dispensing of Primary Packaging Materials :

[][]Obtain Line Clearance approval from Executive, Quality Compliance before starting the dispensing activity.
[][]Operator shall bring required primary packaging materials from ‘Material Staging Area’ and transfer them one by one to dispensing area.
[][]Operator shall check status labels affixed on the container & simultaneously checked by Executive, Production and Executive, Quality Compliance.
[][]In case of spillage of any primary packaging material during dispensing, collect and weigh the quantity of spillage and destroy.
[][]During weighing of each material, ensure zero on weighing scale before proceeding for dispensing.
[][]Weight the empty Polybag and tare the weight by pressing ‘Tare’ button. Then record in ‘MATERIAL DISPENSING SLIP’.
[][]Loose container/ bag should be taken first for dispensing.
[][]Transfer the required quantity of material into tare polybag as per BOM and record the weight in ‘MATERIAL DISPENSING SLIP’.
[][]Remove the issued material from the weighing balance and keep them on the respective material holding SS Cage Trolley.
[][]After completion of weighing of all materials transfer into the ‘Dispensed Material Staging’ Area & keep the room locked.
[][]In case any quantity of the material is left in original container / bag, affix ‘LOOSE LABEL’ on container/bag.
[][]Keep the Loose bags or containers in ‘Broken Bulk’ room. Send back them to PM Store through Airlock corridor.
[][]At the time of Dispensing, Operator shall fill the details of each dispensed material in the BOM and simultaneously cross checked by Executive, Production and Executive, Quality
Assurance
[][]Operator shall prepare ‘MATERIAL DISPENSING SLIP’ for each dispensed Materials and which shall be simultaneously checked by Executive, Production and verified by Executive, QA
[][]Operator shall sign in the column marked as ‘Dispensed by’ in BOM after issue of each and every primary packaging material at the time of dispensing.
[][]Executive, Production shall sign in the column marked as ‘Checked by’ in BOM against each and every primary packaging material.
[][]Executive, Quality Assurance  shall sign in the column marked as ‘Checked by’ in BOM against each and every primary packaging material.
[][]In case of any adverse observation, report to Executive, Assurance for corrective action.
[][]Deface all the labels of empty containers / polybags / boxes with cross marking and transfer them to the scrap area through designated route.
[][]On completion of Dispensing, clean the dispensing area, booth and balances as per respective cleaning procedures & record the same in log book. Hang the status label ‘CLEANED’ outside the door.

Raw & Primary Packaging Materials Dispensing Read More »

Digital Weighing Balance Operation, Cleaning at Production Area

Production, SOPs

Digital Weighing Balance, Purpose:

Digital Weighing Balance, To lay down the procedure for operation, accuracy check and cleaning of the weighing balances at the Production Area.

Digital Weighing Balance, Scope:

This SOP is applicable for 320 g & 60 Kg weighing balance for weighing of materials at the Production Area of XX Pharmaceuticals Ltd.

Definition / Abbreviation:

N/A.

Responsibilities:

[][]The Roles and Responsibilities are as follows:

Operator

[][]To follow the laid down procedure

Executive, Production

[][]To monitor and check the cleanliness of area

Manager, Production

[][]To implement this correctly

Manager, Quality Assurance

[][]To approve the Document

Procedure:

Precaution:

[][]Do not pour liquids on the weighing platform.
[][]Do not use solvents to clean the platform.
[][]Ensure balance is clean before use, including its surrounding area.
[][]Check and ensure the due date of calibration before use.
[][]Check and ensure the level indicator of weighing balance is in the middle, if applicable.
[][]Use hand gloves to hold standard weights for function check and calibration.

Daily Performance Check :

[][]Plug in the power cord.
[][]Level the balance using leveling feet so that air bubble is centered within circle of level indicator.
[][]TO turn the balance ON, short pressing the <O/T> key.
[][]Wait a while so that the stability indicator [*] is displayed.
[][]Zero the balance by pressing the >O/T> key.
[][]Press the 100 mg mass at the centre of the platform and record the value displayed in the daily balance check logbook.
[][]Press the 100 g mass at the centre of the platform and record the value displayed.
[][]Press the 200 g mass at the centre of the platform and record the value displayed.
[][]Print the results by pressing print ( ) button if necessary.
[][]Record the value of those weights in Log Book for ‘Daily Accuracy Check’ (Annexure – I).
[][]If any displayed value is out of acceptable limit, label the balance “DO Not Use” and inform the QA Executive for immediate calibration of the balance.
[][]Balance accuracy check must be performed at the starting of the day.

[][]If the factory remains close for the day(s), put the comments in the remarks column against that day(s) at the day of factory resume.

Operation of 320 g Balances of Mettler Toledo :

To start up:

[][]Level and adjust at each time it is moved to a new location. The balance is exactly horizontal when the air bubble is in the middle of the level glass. Adjust the two front leveling feet appropriately until the air bubble comes to rest exactly in the middle of the glass.
[][]Plug the AC adapter and connect the power supply. Connect the printer to the balance (if available).
[][]Switch on the printer using I/O switch.
[][]Press On/Off ( ) button to on the Electric Analytical Balance. Display will show 0.000g.
[][]Convert the weighing unit from g into mg, press scroll down ( ) button if necessary.
[][]Allow the balance to warm up to enable it to adapt itself to the ambient condition.
[][]Long press for menu ( ) button and select ‘BASIC’ by single press Enter button ( ).
[][]Set date, time and unit using – /+ keys and Enter button ( ) and save the settings using ( ) button.
[][]Press cancel (C) button to return come out of that ‘BASIC’ option and return to its main menu.

[][]Perform the ‘Daily Accuracy Check’ (Annexure – I) at the starting of the day.

Weighing:

[][]Check the machine is clean and calibrated. Then remove all loads from weighing pan.
[][]When zero (0.000 g) reading is displayed, the balance is ready for operation. If the display shows greater than or less than zero, press tare ( O/T ) button to tare the balance.
[][]If the balance is not in the weighing mode, press and hold the ( ) key down until ‘WEIGHING’ in the display.

[][]Use handle/coupling element for the operation of the draft shield door of the both side of the instrument.
[][]Open right/left/upper sliding window of the instrument.
[][]Place empty container/weighing paper on the pan of the balance. Close the sliding window.
[][]The weight is displayed. Allow the reading to stabilize and wait until the instability detector (O) disappears from the left side of the display and the stability beep sounds.
[][]Press tare ( O/T ) button to tare the balance. When zero (0.000 g) reading is displayed, the balance is ready for weighing.
[][]The weighing-in aid is a dynamic graphic indicator which shows the used amount of the total weighing range. It can be recognized at a glance when the load on the balance approaches the maximum load.
[][]Add weighing sample (Maximum 320g) on the container/weighing paper using weighing spoon. Close the sliding window. The net weight is now displayed.
[][]Allow the reading to stabilize and wait until the instability detector (O) disappears for the display and the stability beep sounds.
[][]To get printout of the weight, press print ( ) button.

[][]For performing another weighing press tare ( O/T ) button to tare the balance and follow steps from previous steps To increase or decrease digit, press display resolution ( ) button.
[][]Finally, press and hold On/Off button ( ) button until ‘SHUT OFF’ shows on the display.

Calibration:

Internal Calibration:

[][]Manual Adjustment with Internal weight:
[][]Long press menu ( ) button and press scroll down ( ) button to go to ‘ADVANCED’ option.
[][]Select ‘ADVANCED’ by pressing Enter ( ) button.
[][]Press scroll down ( ) button once to select ‘CAL’ option by pressing Enter ( ) button.
[][]Then select ‘ADJ. INT’ using scroll down ( ) button and then press Enter ( ) button.
[][]Press cancel (C) twice and save the settings if required by scrolling down ( ) button and press Enter ( ) button and then return to its main menu.
[][]Unload weighing pan Press and hold calibration ( ) button to execute ‘Internal Adjustment’.
[][]The balance adjusts itself automatically. The adjusting is finished when the message “ADJ.DONE” appears briefly on the display. The balance returns to the last active application and is ready for operation.

[][]After adjustment, the result of the calibration will be printed out automatically or press print ( ) button for print copy.

External Calibration:

[][]Manual Adjustment with External weight:
[][]Follow the instruction from previous steps
[][]Select ‘ADJ. EXT’ by using scroll down ( ) and then press Enter ( ) button.
[][]Set the adjustment weight (100g) by using -/+ key for External Calibration and press Enter ( ) button.

[][]Then press cancel (C) button twice and save the settings if required by using -/+ key and press Enter ( ) button and then return to its main menu.
[][]Unload weighing pan Press and hold calibration ( ) button to execute ‘External Adjustment’.
[][]The required predefined adjustment weight value flashes on the display.
[][]Place adjustment certified weight on the center of pan. The balance adjusts itself automatically.
[][]When ‘0.00 g’ flashes, remove the adjustment weight.
[][]The adjustment is finished when the message ‘ADJ DONE’ appears briefly on the display. The balance returns to the last active application and is ready for operation.
[][]After adjustment, the result of the calibration will be printed out automatically or press print ( ) button for print copy.

Operation of 60 kg Balances of Mettler Toledo:

[][]Using an Empty container for Weighing:
[][]Press the zero button.
[][]Place an empty container on the scale platform.
[][]Press the Tare button.
[][]Fill the container with material to be weighed.

[][]The terminal will display the net weight and the NET cursor will light up. Allow the reading to be stable. Write down the reading.
[][]To clear a tare weight (with the scale in the net weight mode and a tare weight previously entered), press the Clear key (C).

Without using an Empty container for Weighing:

[][]Press the zero button.
[][]Place the material to be weighed on the scale platform.
[][]The terminal will display the net weight and the NET cursor will light up. Allow the reading to be stable. Write down the reading.
[][]Perform the ‘Daily Accuracy Check’ (Annexure – I) at the starting of the day.

Acceptance Criteria:

[][]The observed weights should be within ± 0.1% of the certified standard weights.
[][]If the acceptance criteria are not satisfied, follow the procedure for Handling of out of calibration for instrument & equipment.

Calibration:

[][]Perform the routine calibration half year. Recalibration is required in the following cases :
[][]After any minor service has been done or replacement of parts.
[][]When the software or firmware has been upgraded or changed.
[][]If daily check fails

Cleaning:

[][]Place the status label ‘TO BE CLEANED’  on the equipment.
[][]Switch off the balance and unplug from the socket.
[][]Remove all objects from the weighing platform of balance.
[][]Lift up and remove the weighing pan in such a way that there is no damage in weighing system.
[][]Clean the pan including underside using a piece of dry cloth. Use wet cloth and finally clean with disinfection solution
[][]Wipe the display, switch board and cables with dry cloth.
[][]Remove ‘TO BE CLEANED’ and affix ‘CLEANED’  label on the equipment after approval from Quality Compliance.
[][]Record the cleaning parameters on the ‘Equipment Log Book’

Annexure: Digital Weighing Balance

Annexure I – Daily Accuracy Check.

Digital Weighing Balance Operation, Cleaning at Production Area Read More »

Monitoring of Room Condition at Production Area.

Production, SOPs

Monitoring of Room Condition, Purpose:

Monitoring of Room Condition, To lay down the procedure for monitoring of Temperature, Relative Humidity (%) and Pressure Gradient at the Production Area.

Monitoring of Room Condition, Scope:

This SOP is applicable for the Production Area of General Block of the XX Pharmaceuticals Limited.

Definitions / Abbreviation:

[][]N/A.

Responsibilities:

[][]The Roles and Responsibilities are as follows :

Operator

[][]To follow the laid down procedure

Executive, Production

[][]To monitor and check the procedure is followed

Manager, Production

[][]To implement this correctly

Manager, Quality Assurance

[][]To approve the Document

Procedure :

Precaution :

[][]Do not use a new hygrometer unless it is calibrated.
[][]When any hygrometer is shifted from one location to another, allow to stabilize the device prior to record the temperature / Relative Humidity (%).
[][]Check the due date of calibration of the hygrometer and magnehelic gauge before taking reading.
[][]Ensure that temperature and Relative Humidity (%) readings are taken before going to operation.

[][]Temperature and Relative Humidity (%) (using Digital Hygrometer)
[][]Ensure that no dust is accumulated over the sensor.
[][]Read the temperature and relative humidity (%) values displayed on the screen of digital/analog hygrometer and record in ‘Temperature, Relative Humidity (%) & Pressure Gradient Records’ (Annexure-I).
[][]Acceptance Criteria:

AreaTemperatureRelative Humidity (%)
Dispensing, Material Staging, Dispensed Material Staging, D Corridor, Wash Bay, Clean Equipment, Broken Bulk, FBD Bag Store, Solution Preparation, Clean Equipment, Encapsulation, WIP Granules, WIP Tablet & Capsules, Coating, Tools Storage, Office Room, Coating Solution Preparation, D Dress Washing & Drying, Foil/Film Staging, Blister Packaging and Dry Syrup Filling & Sealing.Not more than (NMT) 25°CNot more than (NMT) 60 %
Granulation, Blending, Tablet Compression.Not more than (NMT) 25°CNot more than (NMT) 45%

Pressure Gradient

[][]Read the pressure differential from magnehelic gauge provided and record.
[][]If the reading is not within limit, check whether all the doors are closed.
[][]Observe the second reading.
[][]Even if the second reading is not within the limit, inform the Engineering department for corrective action.

AreaPressure Differential
Processing Units
Negative with respect to corridor (i.e. Air Flow is from corridor to processing unit)
10 – 20 Pascal
Wash Bay
Positive with respect to Corridor (i.e. Air Flow is from Wash Bay to Corridor)
10 – 20 Pascal

Frequency

[][]Twice in a shift, first before starting the operation and second after four hours.
[][]If the reading is not within limit at any time of operation, inform the Engineering department immediately and take following steps in different areas.
[][]At Dispensing area stop weighing process, close the bags / high density polyethylene (HDPE) drums of raw materials.
[][]At Granulation area, stop transfer process of materials if running and close the SS / HDPE container with lid.
[][]Do not discharge if temperature and relative humidity (%) or pressure gradient are not within limit.
[][]At Blending area, continue blending process if already running.
[][]At Compression area, stop operation and close the tablet SS/HDPE container lid. Do not keep the granules in the hopper during overnight.
[][]Empty the hopper and close the lid of SS / HDPE container.
[][]At Encapsulation area, stop operation and close the capsule SS/HDPE container lid. Do not keep the granules / pellets in the hopper during overnight. Empty the hopper and close the lid of SS/ HDPE container.

[][]At Coating area, continue operation if already running, otherwise stop operation. Do not unload if temperature and relative humidity (%) or pressure gradient are not within limit.
[][]At Powder filling area, stop the operation. Do not keep the granules in the hopper during overnight.
[][]Empty the hopper and close the lid of SS / HDPE container.
[][]At Blister Packing area, close the lid of tablet / capsule container, close the hopper with lid and stop further operation.

Annexure:

Annexure I – Room Condition Monitoring Logbook

Monitoring of Room Condition at Production Area. Read More »

Utensils Cleaning & Storage for Production are & Dispensing

SOPs

Utensils Cleaning & Storage, Purpose:

Utensils Cleaning & Storage, To lay down the procedure for Cleaning and Storage of Dispensing and Production Utensils.

Utensils Cleaning & Storage, Scope:

This SOP is applicable for the Production Area of  XX Pharmaceuticals Limited.

Definitions / Abbreviation:

N/A.

Responsibilities:

[][]The Roles and Responsibilities are as follows:

Operator

[][]To follow the laid down procedure

Executive, Production

[][]To monitor and check the laid down procedure

Manager, Production

[][]To implement this correctly

Manager, Quality Assurance

[][]To approve the Document

Annexure:

[][]N/A.

Procedure:

Precaution :

[][]Do not clean/disinfect the area when the process is running.
[][]Do not touch the cleaned equipment/utensils without wearing hand gloves.
[][]Always store small items like dispensing scoop, spatula, spoon, mug etc. in polythene bags in
[][]closed condition in clean equipment store after cleaning
[][]If clean equipments/ utensils remain unused for more than three days or 72 hours clean them again before use.
[][]Unclean equipments/ utensils must be cleaned after completion of work on regular basis.

Cleaning Tools / Agents

[][]Cloth & wiper
[][]Potable water and Purified water
[][]Nylon brush

Cleaning of Utensils

[][]Place all unclean production utensils on a trolley or in a polythene bag and label it as
[][]‘TO BE CLEANED’ and transfer them to washing area for cleaning.
[][]First wiping with dry cloth to remove loose dust. Clean them using cloth and potable water. Use hot water and nylon brush if required.
[][]After cleaning with potable water, finally rinse them with purified water. Then wipe with clean lint free cotton cloth to remove water.
[][]After final cleaning let them drying by dryer.
[][]After drying take them separately in closed polythene bag and then keep them in an equipment
[][]cabinet & label with ‘CLEANED’  status label.
[][]Clean hoses/pipes first with potable water and cloth and finally with purified water. Use hot water if required. After cleaning wrap them with polythene. Removal of water then label as ‘CLEANED’status label.
[][]These cleaned items will directly be taken for processing purpose.
[][]Frequency of Cleaning
[][]During product to product change over.
[][]Dispensing scoop, spatula, spoon used in production area to be cleaned during batch to batch change over.

Cleaning of Containers (SS/HDPE)

[][]Clean the containers used for holding intermediate bulk products after each stages of manufacturing activities by following below mentioned procedure. For holding coated tablets, use the same containers holding compressed tablets after wiping with dry cloth to remove loose dust.
[][]Transfer unclean container with a label ‘TO BE CLEANED’ to washing area for cleaning.
[][]Clean the container and lid with dry cloth to remove loose dust then with potable water.
[][]Finally clean with purified water and wipe with clean lint free cloth to remove water.
[][]Remove the ‘TO BE CLEANED’ label and label as ‘CLEANED’ status label.
[][]Frequency of Cleaning
[][]During product to product change over.
[][]Dry clean during batch to batch change over.

Utensils Cleaning & Storage for Production are & Dispensing Read More »

Production area Cleaning Procedure

Production, SOPs

Production area Cleaning Procedure, Purpose:

Production area Cleaning Procedure, To lay down the procedure for effective Cleaning of Production area during Product to Product change over, Batch to Batch change over and at the end of day’s operation.

Production area Cleaning Procedure, Scope:

This SOP is applicable for the Production Area of  XX Pharmaceuticals Limited.

Definitions / Abbreviation:

[][]N/A.

Responsibilities:

[][]The Roles and Responsibilities are as follows:

Operator

[][]To follow the laid down procedure

Executive, Production

[][]To monitor and check the cleanliness of area

Manager, Production

[][]To implement this correctly

Manager, Quality Assurance

[][]To approve the Document

Procedure:

Precaution :

[][]Do not clean/disinfect the area when the process is running.
[][]Keep the cleaning agents at the designated place only with proper labels.
[][]Ensure that after usage the wet mops are washed and hanged in hanger in cleaner store &allowed to dry. Ensure other cleaning tools are also hanged in hanger after use.
[][]After use of cleaning agent wash hands, feet and fingers thoroughly with soap & plenty of water.
[][]Ensure that during cleaning all the product containers are closed.
[][]Check and ensure that disinfectant solution prepared is not stored for use for the next day and the residue is discarded by pouring into drain.
[][]At least two different disinfectants are to be used alternatively on weekly basis.
[][]Do not mop the floor after keeping ‘Cleaned’ equipment in clean equipment storage room.

Cleaning Tools / Agents

[][]Portable vacuum cleaner
[][]Cloth & wiper
[][]Potable water and Purified water
[][]Glass Cleaning agent: ‘Clear View’ (Brand Name)
[][]Disinfectant Savlon (Cetrimide + Chlorhexidine Gluconate) / Dettol (Chloroxylenol) / Clotec (Hypochloride).

Preparation of 2.5 % v/v Savlon/ Dettol/Clotec

[][]To make 10 L disinfectant solution take 0.250 L Cetrimide + Chlorhexidine Gluconate/ Chloroxylenol / Hypochloride in freshly collected purified water to make up volume up to 10 L.
[][]Stir well to mix the solution properly.
[][]Prepare the disinfectant solution separately in separate bucket for use in different floor.
[][]Maintain the ‘Disinfectant Solution Preparation Record’ (Annexure – I).

Product to Product Cleaning Procedure (Type – A Cleaning) for Production Area

[][]Type – A cleaning is defined as cleaning procedure followed during product to product changeover.
[][]If the unit/equipment is used for same product it has to be cleaned after 72 hours.
[][]Place the status label ‘TO BE CLEANED’ (As per Form No. SOP/QCOM/008/XI) in the Area.
[][]Clean the ceiling, walls, outer surface of light fixtures, supply diffusers (SD) and return grills (RG) first with portable Vacuum cleaner to remove loose dust using a platform trolley, then with wet mop.
[][]Clean the machine/equipment in Production area as per SOP.
[][]Clean the doors, compressed air lines and other service lines with dry cloth.
[][]Clean the glasses with ‘Clear View’ solution and wipe.
[][]Clean the control panels, electrical wires with dry cloth.
[][]Clean toolbox, Batch Manufacturing Record table, log books, SOP holders, hygrometer, stool / chair with dry cloth.
[][]Clean the floor first with dry mop, then with potable water and mop with disinfectant solution. Finally clean with purified water.
[][]Ensure after inspection for absence of any residue of previous product. If any residue of previous product or extraneous matter is found, re-clean the area using above procedure until the area is free of any residue/ extraneous matter.

[][]Remove ‘TO BE CLEANED’ and affix ‘CLEANED’ (As per Form No. SOP/QCOM/008/IX) label in the cleaned area after approval from Quality Compliance.
[][]Record the cleaning activity in ‘Room Cleaning Log Book’ (Annexure – II).

Frequency of Cleaning

[][]During product to product change over.
[][]After 3 days or 72 hours from the date of use of the equipment or area. If any batch is running and 72 hours time exceeds during the batch running period, cleaning shall be done after the batch is finished. If 72 hours time exceeds after cleaning and the equipment or area is not used, use the equipment or area after performing B-type cleaning.

Batch to Batch Cleaning (Type-B Cleaning) for Production area

[][]Type – B cleaning is defined as cleaning procedure followed during batch to batch changeover of a
same product.
[][]Place the equipment status label ‘PARTIALLY CLEANED’ (As per Form No. SOP/QCOM/008/X) in the area.
[][]First clean the floor, ceiling, walls, outer surface of light fixtures, supply diffusers (SD), return grills, (RG) doors and equipment with portable vacuum cleaner to remove the loose dust. [][]Finally clean the floor with wet mop.
[][]Remove ‘PARTIALLY CLEANED’ and affix ‘CLEANED’ (As per Form No. SOP/QCOM/008/IX) label in the area.
[][]Record the cleaning activity in Room Cleaning Log Book.
[][]Frequency of Cleaning
[][]During batch to batch change over

[][]Cleaning at the End of Day’s Operation
[][]Clean external parts of the machine, and operating panel with dry cloth.
[][]Clean the floor first with dry mop, then with potable water and mop with disinfectant solution. Finally clean with purified water.

Annexure:

Annexure I – Disinfectant Solution Preparation Record.
Annexure II – Room Cleaning Log Book.

Production area Cleaning Procedure Read More »

Calibration of Friability Tester With Operation & Cleaning

Product Development, SOPs

Calibration of Friability Tester, Purpose :

Calibration of Friability Tester, The purpose of this SOP (Standard Operating Procedure) is to describe the operation, calibration and cleaning of friability tester.

Calibration of Friability Tester, Scope :

This procedure is applicable for friability tester (Model: Electrolab, EF-1W ) used in Product Development Laboratory of XX Pharmaceuticals Limited.

Definitions / Abbreviation:

[][]PD: Product Development

Responsibilities:

[][]The roles and responsibility is as follows:

Executive, PD

[][]To ensure that this procedure is followed.
[][]To maintain the records properly as per SOP.

Sr.Executive, PD

[][]To ensure that this procedure is kept up to date.
[][]To arrange training on the SOP to all concerned personnel.
[][]To ensure implementation of the SOP after training.

Manager, Quality Assurance

[][]Approval of the SOP.

Procedure:

Precaution(s):

[][]Make sure the knob is properly fitted on the shaft to assure the drum is held in position.
[][]Do not hold the drum while they are rotating.
[][]Do not use abrasive, aggressive material or solvents to clean the drum and the tray. If required use mild detergent.
[][]Do not use wet drum. Make sure the drum is dry when in use.
[][]Replace the fuse with the correct rating whenever required.

Operating Procedure:

[][]Turn on the power switch of Friabilator.
[][]After power on, the drum would initialise itself to the loading position and the instrument will initialise the weighing scale and the following display will be shown:

ELECTROLAB
EF 1 W FRIABILATOR

[][]The instrument is then ready for the setting of test parameter and to run the test and following display will be shown on the screen:

ELECTROLAB EF 1 W
SET = menu, START = run
[][]Press SET key to set the test parameter as the following way.
[][]The first parameter for the test is MODE selection. Select the Time or Count mode using the MODE key on the front panel. The desired value for the selected mode can be set using or & DIGIT SCROLL keys. Set Count 100 and Time 4 minutes. Press the ENTER key to go to the next parameter.
[][]The next parameter is RPM setting. The desired value from 20 RPM to 50 RPM can be set using the key or and DIGIT SCROLL keys. Set 25 RPM. Press the ENTER key to go the next parameter.
[][]The next parameter is for drum selection. Using the or keys the Friability or the Abrasion drum can be selected. Select the Friability drum. Press the ENTER key to go the next parameter.
[][]The next parameter is for selecting the Scale Connection Option. This option can be enabled (Y) or disabled (N) using or key. If no printer is connected select disabled (N) mode. Press the ENTER key to go to the next parameter.
[][]The next menu is for Clock setting. The default setting for this menu would be the current time. The Time can be adjusted using or key & DIGIT SCROLL key. Press the ENTER key to go to the next parameter.
[][]The next menu is for Date setting. The default setting for this menu would be the current date. The Date can be adjusted using or key & DIGIT SCROLL key. Press the ENTER key to go to the next parameter.
[][]The next menu is for the selection of the option to the last test result. Select No (N) by using or key. Press the ENTER key to go to the next parameter.
[][]The next menu is for the Sound option. Select Yes (Y) using or key.
[][]Press the SET key to exit from the SET menu.
[][]After weighing the test samples as per specific Standard Test Procedure, slide them gently into the drum through the side slit and press START key, input the weight of tablets, press ENTER to run the test.
[][]After the test is over, the drum rotates in the reverse direction, discharging all the test samples into the tray located below the drum.

[][]The drum would now initialize itself to the loading position. Carefully slide the tray out and remove the loose dust from the test samples, i.e. deduct the test samples. After deducting weight the sample, input the weight of deducted tablets, press ENTER, % friability will be displayed on the screen.
[][]Press SET key for performing a new test.

Calibration procedure:

[][]Ensure that the instrument is clean before use, including surrounding area.
[][]Check and ensure due date of calibration.
[][]Switch ON the power supply.
[][]Set the time 4.0 minutes by selecting TIMER key and start the machine and calibrated stopwatch simultaneously.
[][]Note the actual time shown by a calibrated stopwatch.
[][]Take three such readings and calculate the mean time.
[][]Set 100 counts (rotation) by selecting COUNT key (some tablets may be placed into the drum for ease of counting) and start the instrument.
[][]Record the number of rotation.
[][]Take three such readings and calculate the mean of rotation per minute.
[][]Record the observations in the Calibration report (Annexure –II).
[][]After completion of calibration switch ‘OFF’ the main supply.
[][]After completion of the calibration activity, affix the duly filled and signed calibration status label on the instrument.
[][]Calibration Frequency: Every three-month ±07 days of due date and after maintenance job.

Cleaning procedure:

Remove the knob by pressing gray colored button and open the drum.
Clean the drum with suitable dry duster or cloth.
If required use water and dry in air.
Place the drum properly and replace the knob.

Annexure:

Annexure-I: Log Book Of Friability Tester.
Annexure-II: Calibration Report Of Friability Tester

Calibration of Friability Tester With Operation & Cleaning Read More »

Calibration of Moisture Analyzer with Operation, and Cleaning

Product Development, SOPs

Calibration of Moisture Analyzer, Purpose :

Calibration of Moisture Analyzer, The purpose of this SOP (Standard Operating Procedure) is to describe the operation, calibration and cleaning of Moisture Analyzer.

Calibration of Moisture Analyzer, Scope :

This procedure is applicable for Moisture Analyzer (Model: METTLER TOLEDO, MJ33) used in the Product Development of XX Pharmaceuticals Limited.

Definitions / Abbreviation:

N/A

Responsibilities:

The roles and responsibility is as follows:

Operator / Supervisor, Product Development

[][]To ensure that this procedure is followed.
[][]To maintain the records properly as per SOP.

Executive / Senior Executive, Product Development

[][]To ensure that this procedure is kept up to date.
[][]To arrange training on the SOP to all concerned personnel.
[][]To ensure implementation of the SOP after training.

Manager, Quality Assurance

[][]Approval of the SOP.

Procedure:

Precaution(s):

[][]Keep sufficient free space around the instrument to avoid heat accumulation and over- heating.
[][]Never cover, plugged, taped over or tampered with any way the vent over the sample.
[][]Do not place any combustible material on, under or next to the instrument during operation.
[][]Be very careful to touch sample, sampling pan, sampling pan holder and heating module just after the operation.

Operating Procedure:

[][]Switch on the main power. Instrument shows “OFF” in display.
[][]Press the “ON/OFF” key to switch the instrument on.
[][]The instrument performs a self-test. Wait until the display shown 0.000 g.

Temperature setting

[][]Press the temperature setting key
[][]In display temperature reading shall be blinking.
[][]Select the desire temperature by pressing scroll button
[][]Press enter key to conform the temperature.
[][]Open the heating module (Top lid) for tare and close the heating module.
[][]Again open the heating module and put the sample on sample pan as mentioned in BMR or test procedure.
[][]Close the heating module and wait for buzzed.
[][]Record the moisture content from the display.
[][]Press the “ON/OFF” key to switch off the instrument.
[][]Wait sufficient time to cool down the instrument in ambient temperature before cleaning.

Calibration Procedure:

Balance calibration

[][]Ensure that the sample pan is in position.
[][]Switch ON the power supply. The display shows “OFF”.
[][]Press the “ON/OFF” key to start the instrument.
[][]The instrument performs a self-test. Wait until the display shown 0.000 g.
[][]Select standard weight of 1g, 5g and 10 g for calibration.
[][]Open the heating chamber and place 1g standard weight on the balance pan at center position.
[][]Repeat previous step no.for 5g. & 10 g.
[][]Record the observations in the calibration report (Annexure–II)

Temperature calibration

[][]Press menu key twice. Display shows “Temperature adj.”
[][]Select “Yes” using scroll keys.
[][]Press “enter” key to start process. Display shows “Remove pan holder”
[][]Open the heating chamber and Remove the sample pan holder from the sample chamber.
[][]Display shows “Insert adjustment kit”. Place the temperature adjustment kit (standard thermometer) in the sample chamber.
[][]Close the heating module to start heating to temperature 100deg. C. The display shows the temperature.
[][]Wait 15 minutes, instrument gives audio signal sound.
[][]Note down the actual temperature on standard thermometer in calibration report (Annexure-II)
[][]Press enter key. The heating module automatically starts calibration at 160deg. C.
[][]Again wait for 15 minutes, instrument gives audio signal sound.

Acceptance Criteria

[][]For balance calibration ± 0.1 % & for temperature calibration ± 30 C.
[][]After completion of calibration switch “OFF” the main supply.
[][]After completion of the calibration activity, affix the duly filled and signed calibration status label on the instrument.
[][]Calibration Frequency
[][]Every six month ± 10 days of due date and after maintenance job.

Cleaning Procedure:

[][]Disconnect the instrument from the power supply before cleaning.
[][]Open the heating module and remove the sampling pan by sampling pan holder.
[][]Clean the sampling pan with soft brush.
[][]Clean exteriors of the instrument by clean dry cloth.
[][]Set the parts of weighing pan carefully and close the heating module

Annexure:

Annexure-I: Log Book Of Moisture Analyzer.
Annexure-II: Calibration Report of Moisture Analyzer.

Calibration of Moisture Analyzer with Operation, and Cleaning Read More »

Semi Automatic Disintegration Tester Operation, Calibration and Cleaning

Product Development, SOPs

Semi Automatic Disintegration Tester , Purpose:

Semi Automatic Disintegration Tester , The purpose of this SOP (Standard Operating Procedure) is to describe the operation, calibration and cleaning of Disintegration tester.

Semi Automatic Disintegration Tester , Scope:

This procedure is applicable for Semi Automatic Disintegration tester (Electrolab, Model: ED-2 SAPO) at the Product Development area of XX Pharmaceuticals Limited. This procedure is applicable for Core, Uncoated, Coated tablets and capsules.

Definitions / Abbreviation:

Disintegration Test: The disintegration test is a measure of the time required under a given set of conditions for a group of tablets, Capsule and Other solid dosage forms to disintegrate into particles which will pass through a 10 mesh screen.

Responsibilities:

[][]The roles and responsibility is as follows

Executive, Product Development

[][]To follow the procedure as per SOP.
[][]To maintain the Calibration records.
[][]To ensure cleaning of Disintegration tester maintaining safety rules.

Manager, Quality Assurance

[][]To ensure training and implementation of SOP in department.

Procedure:

Precaution:

[][]Do not switch on the mains if water in the tank is not up to mark.
[][]While placing and removing the basket assemblies do not apply excessive force.
[][]Do not bend the heater while cleaning the water bath.
[][]Do not clean the bath with any strong solvent. Use mild detergents for cleaning.
[][]Lift the machine from the base while lifting or installing.
[][]The external probe should be handled carefully.
[][]To prevent algae propagation in the bath replaces water in the bath at least once in a week.
[][]Remove the external probes when baskets are parked out or removed.
[][]Switch OFF the power supply of the instrument before removing water from the bath.
[][]Do not hold the stirrer while in operation.

Operation: Semi Automatic Disintegration Tester

[][]Ensure the cleanliness of area and the instrument.
[][]Fill the bath with purified water up-to the graduated mark.
[][]Connect the power cord of the instrument to the main power supply.
[][]Check the calibration status of the instrument
[][]Insert the test vessel (jar) in the water bath. Fill the test vessels with purified water / desired media up to 800 ml.
[][]Turn on the power switch provided on the rear side of disintegration tester.
[][]After power on, the instrument will initialize by displaying a power flash screen which will flash twice

DISINTEGRATION
TESTER
ED2-SAPO
VER-1.1

[][]After the power flash screen an idle will be displayed showing the last Mode. Protocol selected for basket A and basket B and the temperature of Jar A, Jar B, and Bath temperature.

Mode: Dual Timer
Proto A: # # Proto B: # #
BATH/ Jar A/ Jar B
# #. /ºC # #. /ºC # #. º

[][]Selection of Registration Mode (For Unknown Disintegration time)
[][]There are two modes: Registration Mode & Dual Timer Mode. Select Registration mode with or keys

Mode: Registration
Proto A: # # Proto B: # #
BATH/ Jar A/ Jar B
# #. /ºC # #. /ºC # #. ºC

[][]Press TEMP key from the front panel a screen will be displayed. Using // key set the temperature to 37.7ºC.
[][]Press TEMP key from the front panel a screen will be displayed. Using // key set the temperature to 37.7ºC.
[][]Press F1 to switch ON the heater. Press TEMP key to register the temperature and come out of the TEMP mode. An idle screen will be displayed. Wait to raise the bath and the jar temperature to desired level.
[][]Assemble the basket-rack.

Operation in Registration Mode

[][]Place six test samples in six tubes. Place the disks if stated in the monographs or in the case of floating products / tablets. Place the disk guides properly to prevent floating of samples.
[][]Press RUN/ HALT key of the respective A or B Jar to run the operation. In Registration mode two separate samples can be tested in two separate jars simultaneously.
[][]Observe the test in each of the tube. If the sample in any of the tube is disintegrated completely just press the key of the respective number. For example if the sample in the number 4 tube of Basket A is disintegrated at first press the number 4 key. Same procedure is followed for all the tubes of each basket.
[][]When Disintegration Time of 6 tablets in one Jar is registered the basket will park out of the media automatically. Press ENTER to return to initial screen.
[][]Observe the disintegration time. To see the time press TIME key. Press F1 to scroll to View Timing mode. Press ENTER. The screen will show the disintegration time of all the six samples. Press F1 key to scroll the screen downward.
[][]To come back into idle screen press ENTER key and press F2 key.

Selection of Dual Timer Mode (For Known Disintegration Time)

[][]When we know the disintegration time of any sample the operation can be done in DUAL TIMER MODE. In this mode there are 10 protocols. An individual sample with its known disintegration time is assigned against each protocol. Select Dual Timer Mode using UP or DOWN keys.
[][]Press TEMP key from the front panel a screen will be displayed. Using BACWARD/UP /DOWN key set the temperature to 37.7ºC.
[][]Press F1 to switch ON the heater. Press TEMP key to register the temperature and come out of the TEMP mode. An idle screen will be displayed. Wait to raise the bath and the jar temperature to desired level.
[][]Press TIME key from the front panel to set the time of a protocol.
[][]When (ARROW) indicates SET TIMER press ENTER button. Using BACWARD/UP /DOWN key adjust the required protocol and time. Press ENTER button to register the time and protocol and come out of the screen.
[][]Press F2 and return to the idle screen.
[][]Assemble the basket-rack.

Operation in Dual Timer Mode

[][]By using BACWARD/UP /DOWN key select different protocols for either jar A or jar B.
[][]Place six test samples in six tubes. Place the disks if stated in the monographs or in the case of floating products / tablets. Place the disk guides properly to prevent floating of samples / disks.
[][]Press RUN/ HALT key of the respective A or B Jar to run the operation.
[][]When the set Time for respective Jar is end up, the basket will park out of the media automatically. Press ENTER to return to initial screen.

Halting / Aborting the Test

[][]Press Run / Halt key to the respective test to be halted.
[][]The respective basket will park out of the media and the display will show the elapse cumulative halt time of the test being halted.

[][]To continue or abort test press Run / Halt key again a screen will be displayed for resuming or aborting the test.
[][]To resume test Press F1.
[][]To abort the test press F2. Press ENTER.

Operation Log Book

[][]Record the information’s in the operational log book- “Operation Log Book of Disintegration Tester (MODEL: ED2-SAPO)”
[][]Calibration of Temperature for Jar A and Jar B
[][]Press TEMP key. Use ▲/◄/▼Key to set the temperature at 37ºC.
[][]Press F1 to switch on the heater. The temperature light will blink.
[][]Press TEMP key to register the temperature and come out of the TEMP mode. An idle screen will display. Wait to raise the temperature at 37.7ºC in the both jars.
[][]When the screen displays a fixed temperature for Jar A and Jar B from temperature sensor, measure the temperature of both Jars by a calibrated thermometer.
[][]Keep the records of calibration as per Annexure-I.
[][]Acceptance Range: ± 2ºC of the display temperature.
[][]Calibration of Timer for Basket-A
[][]Select the Dual Timer mode by pressing ▼/▲key.
[][]Use ◄ key to select Proto A.[START OF SECTION ONE]
[][]Press the option menu.
[][]Press F1 (scroll) key to select set protocol. Press Enter key.
[][]Press ▼/▲ key to set a specific protocol no. (e.g. 01, 02, 03 …) under Proto A.
[][]Press F1 (scroll) key to enter the Timer option.
[][]Set the timer (5 minutes) by using ▲/◄/▼key.
[][]Press F2 key twice to return to the idle screen.
[][]Press the Run key in the front panel and start the calibrated stop watch to compare the time.

[][]After completion of the specified time (5 minutes) ‘Test is over’ is appeared on the screen with beeping sound.
[][]Press Enter key to return to the idle screen.
[][]Keep the records of calibration as per Annexure-I.
[][]Acceptance Range: 5 minutes.[END OF SECTION ONE]

Calibration of Timer for Basket-B

[][]Use ◄ key to select Proto B.
[][]Follow previous steps [START OF SECTION ONE] TO [END OF SECTION ONE]
[][]Calibration of Stroke/min. for Basket-A
[][]Check the jar temperature. If temperature is not in the desired level, wait for raising the temperature (37.7°C) in the jar.
[][]Follow previous steps
[][]Press the RUN key and start the stop watch to count the no. of strokes per minute.
[][]Press the Halt key twice and then Test A is displayed.
[][]Press F2 to abort. The screen will display ‘Test is over’.
[][]Press Enter key to return to the idle screen.
[][]Keep the records of calibration as per Annexure-I.
[][]Acceptance Range: 29 to 32 Stroke/min.
[][]Calibration of Stroke/min. for Basket-B
[][]Follow previous steps(In case of Proto B, Use ◄ key to select Proto B).
[][]Calibration of Traveling Distance for Basket-A
[][]Follow previous steps
[][]Press Run key to travel the Basket A in upward and downward stroke.

[][]When the basket is in the downward stroke position, Press the power switch (Rear side of the instrument) to off quickly.
[][]Now Mark the position (Xa) of the basket holder by a pencil.
[][]Press the power switch on.
[][]Press the TEMP key.
[][]Press F1 to on the heater. The temperature light will blink.
[][]Press TEMP key to return to the idle screen position.
[][]Wait for the desired setting temperature (37°C). When it reaches to the desired level, Press the Run key. The basket will travel upward and downward stroke.
[][]When it comes to the upward stroke position, Press the power switch (Rear side of the instrument) to off quickly.
[][]Mark the position (Ya) of the basket holder by a pencil.
[][]Now measure the traveling distance between Xa and Ya by a standard certified scale.

Xa – Ya= ## mm.
[][]Keep the records of calibration as per Annexure-I.
[][]Acceptance Range: 55 ± 2 mm.
[][]Calibration of Traveling Distance for Basket-B
[][]Press the power switch (Rear side of the instrument) to on.
[][]Press the TEMP key. Use ▲/◄/▼key to set the temperature at 37ºC.
[][]Press F1 to switch on the heater. The temperature light will blink.
[][]Press TEMP key to return to the idle screen position.
[][]Wait for the desired setting temperature (37.7°C). When it reaches to the desired level Press the Option Key.
[][]Follow steps  (In case of Proto B, Use ◄ key to select Proto B).
[][]Follow steps

Calibration of Basket A to Beaker Bottom Height

[][]Unscrew Basket A from the bottom and remove the basket bottom plate.
[][]Remove one tube (with Blue or Brown indication) and engage the basket to the basket holder.
[][]Insert the measuring scale (6 inch) into the disc from where the tubing has been removed. Care should be taken that the scale touches the bottom of the beaker.
[][]Press the power switch (Rear side of the instrument) to on.
[][]Press the TEMP key.
[][]Press F1 to on the heater. The temperature light will blink
[][]Press TEMP key to return to the idle screen position.
[][]Wait for the desired setting temperature (37°C). When it reaches to the desired level, Follow steps
[][]Press the Run key to travel the Basket A in upward and downward stroke.
[][]When the basket is in the downward stroke position, Press the power switch (Rear side of the instrument) to off quickly.
[][]Measure the Basket A to bottom height during the downward stroke by certified measuring scale.
[][]Keep the records of calibration as per Annexure-I.
[][]Acceptance Range: 25 ± 2 mm.

Calibration of Basket B to Beaker Bottom Height

[][]Follow steps

[][]Set the parts of the instrument and clean the instrument.
[][]Calibration Frequency: 3 months ± 10 days.

Cleaning

[][]After completion of a test clean the basket-rack assembly with potable water and if required with a mild detergent.
[][]Whenever required use a suitable brush to remove any residue of the previous sample from the mesh screen.
[][]Use potable water to clean the jar and bath.
[][]Finally rinse the basket rack assembly, jar & bath with purified water and dry in air.
[][]Cleaning frequency of basket rack assembly & jar : After every test
[][]Cleaning frequency of water bath: Once in a week.
Note: In between when water become dirty change water
[][]After cleaning of the disintegration test apparatus water bath, record it as per Annexure-III

Annexure: Semi Automatic Disintegration Tester

Annexure-I: Operation log book of Disintegration Tester(Model: ED2-SAPO)
Annexure –II: Calibration report of disintegration tester.
Annexure-III: Cleaning record for Disintegration water bath.

Semi Automatic Disintegration Tester Operation, Calibration and Cleaning Read More »