Production

Packaging Area Cleaning Procedure

Packaging, Production, SOPs

Packaging Area Cleaning, Purpose:

Packaging Area Cleaning, To lay down the procedure for effective cleaning at the Packaging Area.

Packaging Area Cleaning, Scope:

This SOP is applicable for the Packaging 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, Packaging

[][]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 packing 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
[][]Glass Cleaning agent: ‘Clear View’ (Brand Name).
[][]Disinfectant (Savlon/ Dettol/ Chlotec).
[][]Floor cleaning agent Perfect 7/Enviro Care
[][]Preparation of 2.5 % v/v Chlorhexidine Gluconate Solution
[][]To make 10 L disinfectant solution take 2.5 L Chlorhexidine Gluconate 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’.

Product to Product Cleaning Procedure (Type-A Cleaning) for Secondary Packaging 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’ in the Area.
[][]Clean the ceiling, walls, 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 packaging are As per SOP.
[][]Clean the doors, windows, compressed air lines and other service lines with dry cloth and then wet mop.
[][]Clean the glasses with ‘Clear View’ solution and wipe.
[][]Clean the control panels, electrical wires with dry cloth.
[][]Clean toolbox, table, log books, SOP folders, hygrometer, stool / chair with dry Cloth.
[][]Clean the floor first with dry mop, then with Perfect 7/Enviro Care and finally with potable 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’ label in the cleaned area.
[][]Record the cleaning activity in ‘Room Cleaning Log Book’.

Frequency of Cleaning

[][]During product to product change over.
[][]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 Secondary Packaging area

[][]Type – B cleaning is defined as cleaning procedure followed during batch to batch changeover of a particular product.
[][]Place the equipment status label ‘PARTIALLY CLEANED’ in the area.
[][]First Clean the floor, ceiling, walls, light fixtures, supply diffusers (SD), return grills (RG) doors, windows and equipment with portable vacuum cleaner to remove the loose dust. Finally clean the floor with wet mop.
[][]Remove ‘PARTIALLY CLEANED’ label and affix ‘CLEANED’ 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 and finally with disinfectant solution.
[][]Frequency of Cleaning
[][]At the end of the day’s work.

Packaging Area Cleaning Procedure Read More »

Transfer of Finished Goods to the Finished goods storage area

Packaging, Production, SOPs

Transfer of Finished Goods, Purpose:

Transfer of Finished Goods, To lay down the procedure for to the Finished Goods Storage Area.

Transfer of Finished Goods, Scope:

This SOP is applicable for the Packaging 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, Packaging

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

Manager, Production

[][]To implement this correctly

Head of Quality Assurance

[][]To approve the Document

Annexure:

Annexure I – Finished Goods Transfer Note.
Annexure II – Weight Checking Record of Inner Carton
Annexure III – Weight Checking Record of Shipper Carton

Procedure:

Precautions:

[][]Do not transfer finished goods to the Finished Goods Storage area without Quality Compliance (QCOM) approval.
[][]Warehouse personnel should not receive finished goods from Production without any ‘Finished Goods Transfer Note’.
[][]Ensure that proper labels are on shipper carton & pallet.
[][]Check the weight of individual inner carton and keep record at 30 minutes interval in Annexure-II (Weight Checking Record of Inner Carton).
[][]Attach the Transparent Hologram Sticker on inner carton.
[][]Place the inner cartons in shipper carton and seal the shipper carton using gum tape.
[][]Check and ensure that ‘PRODUCT LABEL’ of shipper carton (Product name, Batch No., Mfg. Date, Exp. Date, Pack Quantity, Sr. No., Packed by, Storage Condition) is legible and clear.
[][]Check the weight of individual shipper carton and keep record of every shipper carton’s weight in Annexure-III (Weight Checking Record of Shipper Carton).
[][]Seal on every shipper carton as the following using rubber stamp (L-3.25 inch X W-2.0 inch) and record the relevant information which corresponds with Annexure-III.

SHIPPER CARTON NO.:………………….

WEIGHT:……………………………………….

NAME:…………………………………………..

SIGNATURE AND DATE:……………….

[][]Keep the shipper cartons on a clean pallet. Use more than one pallet if required to keep shipper cartons on it.
[][]In case of Loose shipper carton affix ‘LOOSE LABEL’ on two sides of shipper carton (Front & Back).
[][]Prepare a ‘Finished Goods Transfer Note’ after completion of packing of a batch as per format (Annexure – I).
[][]QCOM shall affix ‘QUARANTINED’ label on pallet.
[][]When the batch is approved by Quality Compliance (QCOM), hand over the batch along with Finished Goods Transfer Note to warehouse personnel.
[][]Maintain batch details in ‘Finished Goods Register’ Production personnel will sign as ‘Transferred by’ and warehouse personnel as ‘Received by’ in the Finished Goods Register.

Annexure:

Annexure I – Finished Goods Transfer Note.
Annexure II – Weight Checking Record of Inner Carton
Annexure III – Weight Checking Record of Shipper Carton

Transfer of Finished Goods to the Finished goods storage area Read More »

Material Drying Machine Set Up, Operation & Cleaning

Production, SOPs

Material Drying Machine , Purpose :

Material Drying Machine , The purpose of this SOP is to describe the setting, operation and cleaning procedure of Material Drying Machine (Model: Standard) in order to comply with cGMP standard.

Material Drying Machine , Scope :

The scope of the procedure is applicable to the Material Drying Machine (Model: Standard) at the Production area of XX Pharmaceuticals Limited.

Definitions / Abbreviation:

[][]N/A.

Responsibilities:

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

Operator

[][]Sep Up, Operation and cleaning of the Material Drying Machine (Model: Standard)
[][]Maintaining Equipment Log Book

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 :

[][]Make sure that the main power switch is OFF position before and after operation.
[][]Use face mask, rubber gloves and protective clothing during handling of materials.
[][]Check the cleanliness of individual tray and machines inner part during assembling of machine.
[][]Booth side doors are in lock position during operation.
[][]Check the air outlet damper position before and after completion of operation.

Machine Assembling

[][]Keep the necessary change parts near the material dryer machine before assembling.
[][]Assemble the dryer by opening the front side door of the dryer.
[][]Load the tray with material and place into the tray holding rack.
[][]Then set the rack carrying trolley.
[][]Then place the tray holding rack into the machine.
[][]After that closed the door accurately with the help of door locking handle.
[][]Then closed the air outlet damper and tight the screw accurately.

Machine Operation

[][]Switch ON the main power switch.
[][]Open the plastic cover and set the desire temperature of the machine.
[][]Then open the plastic cover and set the desire time of the machine.
[][]At first switch ON the blower of the machine.
[][]Then switch ON the heater of the machine.
[][]After completed the drying time open the air outlet damper for material cooling and check the LOD.
[][]After operation switch OFF the heater and then blower. Unload the tray holding rack from the machine.
[][]Finally switch OFF the main power of the machine.
[][]Record the machine operation parameters in the ‘Equipment Log Book’.

Machine Dismantling

[][]Open the both side door of the machine.
[][]Unload the tray holding rack from the machine with the help of carrying trolley.
[][]Remove the tray from the rack.

Machine Cleaning

[][]Remove dusts from the machine body and other necessary parts with a vacuum cleaner.
[][]Clean all the machine parts with dry lint free cloth.
[][]Use potable water to clean the machine body, product contact parts, tray and other machine parts.
[][]Use hot water to clean all the trays.
[][]Finally rinse the machine body, product contact parts, trays and other machine parts with purified water.
[][]Remove the water with lint free cloth.
[][]After final cleaning affix the ‘CLEANED’ label.
[][]Record the cleaning parameters in the ‘Equipment Log Book’.

Annexure:

Annexure I Equipment Use Log Book

Material Drying Machine Set Up, Operation & Cleaning Read More »

Material Pulverization Machine Set Up, Operation & Cleaning

Production, SOPs

Material Pulverization Machine, Purpose :

Material Pulverization Machine, The purpose of this SOP is to describe the setting, operation and cleaning procedure of the Material Pulverization Machine (Model: 30B) in order to comply with cGMP standard.

Material Pulverization Machine, Scope :

The scope of the procedure is applicable to the Material Pulverization Machine (Model: 30B) at the Production area of XX Pharmaceuticals Limited.

Definitions / Abbreviation:

[][]N/A.

Responsibilities:

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

Operator

[][]Sep Up, Operation and cleaning of the Material Pulverization Machine (Model: 30B)
[][]Maintaining Equipment Log Book

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 :

[][]Make sure that the main power switch is OFF position before and after operation.
[][]Use face mask, rubber gloves and protective clothing during handling of materials.
[][]Check the cleanliness of sieves, ss container, tray and gasket before assembling of machine.
[][]Check the sieve for its integrity before and after completion of operation.

Machine Assembling

[][]Keep the necessary change parts near the machine before assembling.
[][]Assemble the machine by opening the front side cover of the machine.
[][]Adjust the sieve into the ring with the help of screw.
[][]Then set the sieve ring into the machine.
[][]Close the cover of the machine properly.
[][]Set the filter bag of the machine with the help of spring and clamp.
[][]Place the tray under the filter bag.

Machine Operation

[][]Switch ON the main power switch.
[][]Switch ON the blower by pressing green button of the machine.
[][]Then switch ON the motor by pressing green button of the machine.
[][]Input the material through the hopper of the machine manually.
[][]Sieve the material and collect sieved material through the cover discharge opening.
[][]After operation first switch OFF the motor then switch OFF the blower by pressing red button.
[][]Record the machine operation parameters in the ‘Equipment Log Book’.

Machine Dismantling

[][]Open the front cover of the machine.
[][]Remove the sieve ring of the machine.
[][]Remove the filter bag of the machine.
[][]Remove the tray of the machine.

Machine Cleaning

[][]Remove dusts from the machine body and other necessary parts with a vacuum cleaner.
[][]Clean all the machine parts with dry lint free cloth.
[][]Use potable water to clean the machine body, product contact parts, tray, container, sieve & filter bag.
[][]Use hot water to clean all the product contact parts such as sieve ring.
[][]Finally rinse the machine body, product contact parts, trays and other machine parts with purified water.
[][]Remove the water with lint free cloth.
[][]After final cleaning affix the ‘CLEANED’ label.
[][]Record the cleaning parameters in the ‘Equipment Log Book’.

Annexure:

Annexure I Equipment Use Log Book

Material Pulverization Machine Set Up, Operation & Cleaning Read More »

Bottle Washing Machine Set Up, Operation And Cleaning

Production, SOPs

Bottle Washing Machine, Purpose :

Bottle Washing Machine, The purpose of this SOP is to describe the setting, operation and cleaning procedure of Glass Bottle Washing Machine (Model: IRW-16) in order to comply with cGMP standard.

Bottle Washing Machine, Scope :

The scope of the procedure is applicable to the Glass Bottle Washing Machine (Model: IRW-16) at the Production area of XX Pharmaceuticals Limited.

Definitions / Abbreviation:

N/A.

Responsibilities:

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

Operator

[][]Set up, operation and cleaning of the Washing Machine (Model: IRW-16)
[][]Maintaining Equipment Log Book

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 :

[][]Make sure that the main power switch is OFF position before and after operation.
[][]Use face mask, rubber gloves and protective clothing during handling of materials.
[][]Check the cleanliness of individual water reserve tank and machines inner part during assembling of machine.
[][]Do not touch the hot water tank during operation.
[][]Check the individual bottle washing nozzle working properly.

Machine Assembling

[][]Keep the necessary change parts near the bottle washing machine before assembling.
[][]Assemble the washing machine by bottle holder.
[][]Load the pump 1 with tap water and pump 2 with hot water.
[][]Load the bottle holder with glass bottle.
[][]Set the nozzle’s spray rate of tap water and purified water depending on the glass bottle size.

Machine Operation

[][]Switch ON the main power switch.
[][]Switch ON the heater switch of the machine and wait 20 minutes for hot water (60ºC).
[][]Then press the START button of the main motor.
[][]After press the START button of the pump 1.
[][]Then press the START button of the pump 2.
[][]Open the valve of compressed air line.
[][]After completing the glass bottle washing procedure close the valve of tap water, purified water & compressed air line.
[][]After operation switch OFF the heater, pump 2, pump 1 and then main motor.
[][]Finally switch OFF the main power of the machine.
[][]Record the machine operation parameters in the ‘Equipment Log Book’.

Machine Dismantling

[][]Open the cover of the machine.
[][]Remove the bottle holder of the machine.
[][]Drainage the water of pump 1 & pump 2.

Machine Cleaning

[][]Remove dusts from the machine body and other necessary parts with a vacuum cleaner.
[][]Use potable water to clean the machine body, product contact parts and other machine parts.
[][]Use hot water to clean all the parts.
[][]Finally rinse the machine body, product contact parts and other machine parts with purified water.
[][]Remove the water with lint free cloth.
[][]After final cleaning affix the ‘CLEANED’ label.
[][]Record the cleaning parameters in the ‘Equipment Log Book’.

Annexure:

Annexure I Equipment Use Log Book

Bottle Washing Machine Set Up, Operation And Cleaning Read More »

Blister Packaging Machine Set Up, Operation & Cleaning

Production, SOPs

Blister Packaging Machine, Purpose :

Blister Packaging Machine, The purpose of this SOP is to describe the setting, operation and cleaning procedure of the Blister Packaging Machine (Model: HM-V3) in order to comply with cGMP standard.

Blister Packaging Machine, Scope :

The scope of the procedure is applicable to the Blister Packaging Machine (Model: HM-V3) at the Production area of XX Pharmaceuticals Limited.

Definitions / Abbreviation:

N/A.

Responsibilities:

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

Operator

[][]Set Up, Operation and cleaning of the Blister Packaging Machine (Model: HM-V3)
[][]Maintaining Equipment Log Book

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 :

Safety

[][]Never run the machine with its door open.
[][]Use face mask, rubber gloves and protective clothing during handling of materials.
[][]Keep the switches “OFF” during break-time and at the end of the job.
[][]Care must be taken to ensure that the drive units and accessory parts cannot be switched on inadvertently after servicing or maintenance work.

Special Instruction

[][]Be sure that the power switches are “OFF” position.
[][]Beware of the high temperature of “Sealing top mold” during cleaning and if possible, allow it to cool down completely.
[][]Should not use methanol or other organic solvent like ethanol, carbon tetrachloride, thinner, benzene etc. to clean plastic doors and other parts of the machine.
[][]Water should not be used to clean metal parts of the machine.
[][]Care should be taken to ensure that no water enters inside the motor.
[][]Corrosive materials should not be used to clean the machine.
[][]Heavy parts should not dismantle alone, always taken help from others.
[][]Machine chiller purified water level should be check fifteen days interval and purified water should be change every three months interval.
[][]Carefulness should be taken about heavy parts handling.

Machine Assembling

[][]Switch on the main power supply of the machine.
[][]Check the draw in of the base film and the lid foil.
[][]Check Compressed air valve open and air pressure above 6 bars.
[][]Turn control panel key “ON”.
[][]Push reset button and press main button.
[][]Press setup button to show password for entering product list.
[][]Select Specific product from product list and press main button.
[][]Adjust draw off length by pressing inching switch according to advance length.
[][]Check the emergency push buttons, safety switches of the safety guards/glass doors.
[][]Press Main button and enter into information and positioning the machine according to following parameter-
[][]Forming station
[][]Sealing station
[][]Embossing
[][]Cooling station
[][]Perforation / Slitting station.

[][]Set following change parts by push inching switch-
Forming
Perforation / Slitting
Cutter
[][]Set following change parts carefully-
Pre-heating
Guide rail
Sealing upper-lower plate.
Embossing
Cooling Plate
Pulling Station
Feeding Tray

[][]Push reset button and checks the machine accurately by inch the inching switch press.
[][]Set bottom foil & lid foil and cutting shall be adjusted by inching switch on manual mode with press-
Heater.
Chiller.
Draw off.
Sealing lift.
[][]Press “Start” button and run machine to check the pocket forming and batch code embossing.
[][]Insert tablets or capsules on the pocket of PVDC/PVC/ALU film on the guide rail and perform a leak test operation of those strips to ensure proper sealing.
[][]Press manual mode and “OFF” all button only the following button shall “ON”
Heater.
Chiller and
Sealing lift.
[][]Convert manual mode to auto mode for running the machine.
[][]After completed the all parts setting, check that every parts are setting properly & proper place.
[][]Ensure that every screw nuts are tight properly.
[][]Set batch code with the respective digit.
[][]Emboss batch code and show Quality Assurance Officer for approval.

Machine Operation

[][]Ensure that area and equipment are clean and suitable to start the operation.
[][]Before starting the blister machine use surgical gloves, nose mask etc.
[][]Set different change parts like forming plate, sealing plate, code embossing, guid rail, cooling plate etc. in proper position.
[][]Set the top Foil (Alu foil) & Bottom Foil (PVC, PVDC & Alu foil) correctly.
[][]Open the compressed air valve & ensure that the air pressure is above 6 bars. Check & ensure that the compressed air is free from moisture.

[][]Temperature for PVDC preheating 110-140ºc and sealing 150-180ºc and for slitting are 60-80ºc & embossing Alu 70-80 ºc, temperature for Alu sealing 160-180 ºc and embossing 70-90 ºc maintained .
[][]Tablets and Capsules are placed manually to the PVDC forming or Alu forming pocked. Different packs are produced for different products by forming, feeding, sealing, punching and discharging.
[][]Machine should be observed very carefully during blistering operation.
[][]Press the stop button in machine after completes the blister operation.
[][]Record the machine operation start time and end time & other parameters in the ‘Equipment Log Book’ .

Dismantling of Change Parts

[][]Change parts should be removed sequentially from the machine with the help of others.
[][]Feeding Tray should be removed by loosing screw nuts.
[][]Guide Rail should be removed by loosing nuts.
[][]Forming Set (Upper & Lower Plate) should be removed by loosing screw nuts.
[][]Cutter should be removed by loosing nuts.
[][]Sealing Upper Plate should be removed by loosing clamp lock.
[][]Sealing Lower Plate should be removed by loosing screw nuts.
[][]Cooling Plate should be removed by loosing screw nuts.
[][]Perforation/ Slitting should be removed by loosing screw nuts.
[][]Heating Plate (In-case of Alu-PVC) should be removed by loosing nuts.
[][]Embossing Plate should be removed by loosing screw nuts and clamp lock.
[][]Change parts should be kept on clean pallets with “TO BE CLEANED” label.

Machine Cleaning

[][]All documents, previous product container and any materials should be removed from the room.
[][]The dust should be cleaned around the machine with the help of vacuum cleaner.
[][]The surface of the machine should be cleaned with lint free cloths with Purified Water or defined cleaning solution starting from top to downwards sequentially at first ceiling, wall, machine and floor.
[][]Safety covers (Door) should be cleaned by the use of wetted smooth lint free cloth with purified water.
[][]Glass and plastic materials should be cleaned by lint free smooth cloth with purified water.
[][]The machine should be moped with a lint free cloth using purified water.
[][]Finally, the machine should be moped with dried lint free cloth.
[][]Record should be taken in equipment machine log book.
[][]Machine accessories should be transferred to the wash room.
[][]“CLEANED” label should be attached to the machine.
[][]Change parts should be dismantled and kept on a clean trolley or pallets with status label and kept the trolley on the washing room for the cleaning at the end of product run.
[][]After cleaning completion the change parts should be stored in tool store with “CLEANED” label.

Annexure:

Annexure I Equipment Use Log Book

Blister Packaging Machine Set Up, Operation & Cleaning Read More »

ROPP Cap Sealing Machine Set Up, Operation & Cleaning

Production, SOPs

ROPP Cap Sealing Machine, Purpose :

ROPP Cap Sealing Machine, The purpose of this SOP is to describe the Operation and cleaning procedure of ROPP Cap Sealing Machine (Model: PPM-35) in order to comply with cGMP standard.

ROPP Cap Sealing Machine, Scope :

The scope of the procedure is applicable to the ROPP Cap Sealing Machine (Model: PPM-35) at the Production area of XX Pharmaceuticals Limited.

Definitions / Abbreviation:

N/A.

Responsibilities:

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

Operator

[][]Setting, operation and cleaning of the Cap Sealing Machine (Model: PPM-35)
[][]Maintaining Equipment Log Book.

Executive, Production

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

Manager, Production

[][]To implement this correctly

Manager, Quality Assurance

[][]To approve the Document

Procedure:

Precaution:

[][]Ensure that area & equipment are clean and suitable to start the operation.
[][]Use protective suit, surgical gloves, head gear, cotton mask, and safety goggles during sealing operation.
[][]In case of emergency, press the emergency switch to stop the machine.

Machine Assembling

[][]Set the base of the machine by specific nut and attach the bottle adjuster.
[][]Set the sealing wheel according to the neck diameter of the bottle.
[][]Fix the bottle size by moving the base.

Machine Operation

[][]Load the bottle on the SS table.
[][]Fix the plastic stopper and aluminum cap on the empty bottle.
[][]Turn on the main switch of the machine.
[][]Take a bottle on the base.
[][]Seal it by the moving sealing wheel.
[][]Check the leakage by leak test apparatus.
[][]If sealing is accurate then another eight empty bottle have to seal.
[][]Take them again for leak test.
[][]Continue the sealing operation if sealing is accurate.
[][]Turn off the all switch gradually after complete the sealing operation.
[][]Record the machine start & end time and other parameters in the ‘Equipment Log Book’

Machine Dismantling

[][]Turn the main switch off.
[][]Dismantle the parts like moving sealing wheel, bottle adjuster unit and transfer them to the wash bay.

Machine cleaning

[][]Remove dusts from the machine with a vacuum cleaner. Collect dust from machine body.
[][]Clean all the machine parts with dry lint free cloth.
[][]Use potable water to clean the machine body and holding screw.
[][]Use hot water to clean all the product contact parts & finally rinse with purified water.
[][]Clean and swab all the parts with lint free cloth to remove water.
[][]After final cleaning affix the ‘CLEANED’ label.
[][]Record the cleaning parameters on the ‘Equipment Log Book’.

ROPP Cap Sealing Machine Set Up, Operation & Cleaning Read More »

Auger Filling Machine Set Up, Operation & Cleaning

Production, SOPs

Auger Filling Machine, Purpose :

Auger Filling Machine, The purpose of this SOP is to describe the setting, operation and cleaning procedure of Auger filling Machine (Model: GZF30B) in order to comply with cGMP standard.

Auger Filling Machine, Scope :

The scope of the procedure is applicable to the Auger filling machine (Model: GZF30B) at the Production area of XX Pharmaceuticals Limited.

Definitions / Abbreviation:

[][]PLC = Programmable Logic Controller.

Responsibilities:

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

Operator

[][]Setting, operation and cleaning of the Auger filling Machine (Model: GZF30B)
[][]Maintaining Equipment Log Book

Executive, Production

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

Manager, Production

[][]To implement this correctly

Manager, Quality Assurance

[][]To approve the Document

Procedure:

Precaution:

[][]Ensure that area & equipment are clean and suitable to start the operation.
[][]Before entering the filling room use protective suit, surgical gloves, head gear, cotton mask, and safety goggles during filling operation.
[][]Do not insert hands inside the hopper during operation; keep the hopper closed after loading.
[][]Make sure that powder is not deposited in hopper, dosing unit and other parts of the machine that must be observed very carefully.
[][]In case of emergency, press the emergency switch to stop the machine.

Machine Assembling

[][]Set the dosing unit by specific nut and attach the supporting parts of dosing unit.
[][]Set the powder hopper with its supporting parts.
[][]Fix the size of the bottle on the machine.
[][]Set the parameters of the machine such as Set Quantity, Actual Quantity and Output on the PLC.

Machine Operation

[][]Load the bottle on the SS table.
[][]Load the powder in hopper and close the lid of hopper.
[][]Turn on the main switch of the machine.
[][]Turn on the vibrator switch.
[][]Mix the powder in the hopper by rotating stick.
[][]Set the filled weight on the PLC.
[][]Adjust the filled weight by pressing leg punch in the empty glass bottle.
[][]Check the fill weight of eight bottles after setting the volts in dose wheel.
[][]Continue the filling operation if fill weight is accurate.
[][]Turn off the all switch gradually after complete the filling operation.
[][]Record the machine start & end time and other parameters in the ‘Equipment Log Book’

Machine Dismantling

[][]Turn the main switch off.
[][]Collect the powder from the hopper and dosing unit by vacuum cleaner.
[][]Dismantle the parts like hopper, auger and dosing unit and transfer them to the wash bay.

Machine cleaning

[][]Remove dusts from the machine with a vacuum cleaner. Collect dust from the hopper, dosing unit, operation panel and machine body.
[][]Clean all the machine parts with dry lint free cloth.
[][]Use potable water to clean the machine body, all product contact parts and holding screw.
[][]Use hot water to clean all the product contact parts.
[][]Finally rinse the machine body, all product contact parts, holding screw and other parts with purified water.
[][]Clean and swab all the parts and the machine body with lint free cloth to remove water.
[][]After final cleaning affix the ‘CLEANED’ label.
[][]Record the cleaning parameters on the ‘Equipment Log Book.

Annexure:

Annexure I Equipment Use Log Book

Auger Filling Machine Set Up, Operation & Cleaning Read More »

Capsule Polishing Machine Set Up, Operation And Cleaning Procedure

Production, SOPs

Capsule Polishing Machine, Purpose :

Capsule Polishing Machine, The purpose of this SOP is to describe the setting, operation and cleaning procedure of the Capsule Polishing Machine (Model: SF-40N) in order to comply with cGMP standard.

Capsule Polishing Machine, Scope :

The scope of the procedure is applicable to the Capsule Polishing Machine (Model: SF-40N) at the Production area of XX Pharmaceuticals Limited.

Definitions / Abbreviation:

N/A.

Responsibilities:

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

Operator

[][]Set up, operation and cleaning of the Polishing Machine (Model: SF-40N)
[][]Maintaining Equipment Log Book

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 :

[][]Make sure that the main power switch is OFF position before and after operation.
[][]Ensure that area & equipment are clean and suitable to start the operation.
[][]Before entering the capsule polishing room use protective suit, surgical gloves, head gear, cotton mask, and safety goggles during polishing operation.
[][]Do not insert hands inside the hopper during operation.
[][]Make sure that capsule is not deposited in hopper and other parts of the machine that must be observed very carefully.
[][]In case of emergency, press the emergency switch of the main encapsulation machine to stop the machine.

Machine Assembling

[][]Set the capsule polishing brush by specific nut and attach the SS cover of the machine.
[][]Set the capsule hopper.
[][]Fixed the empty capsule shell feeder on the machine.
[][]Set the air pressure of the machine.

Machine Operation

[][]Turn ON the main switch of the machine. Then turn ON the switch of the capsule polishing machine.
[][]Turn on the air pressure valve and adjust the air pressure 0.15 to 0.2 bars.
[][]Load the capsule on the hopper.
[][]Check the capsule is polishing accurately.
[][]Continue the polishing operation if capsule polishing is accurate.
[][]Turn OFF all switch gradually after complete the polishing operation.
[][]Record the machine operation parameters in the ‘Equipment Log Book’

Machine Dismantling

[][]Turn the main switch OFF.
[][]Collect the dust from the hopper by vacuum cleaner.
[][]Dismantle the parts like hopper, machine cover, brush and empty shell feeder and transfer them to the wash bay.

Machine Cleaning

[][]Remove dusts from the machine with a vacuum cleaner. Collect dust from the hopper machine body.
[][]Clean all the machine parts with dry lint free cloth.
[][]Use potable water to clean the machine body, all product contact parts and holding screw.
[][]Use hot water to clean all the product contact parts like capsule polishing brush.
[][]Finally rinse the machine body, all product contact parts, holding screw and capsule polishing brush with purified water and dry the brush properly after cleaning.
[][]Clean and swab all the parts and the machine body with lint free cloth to remove water.
[][]After final cleaning affix the ‘CLEANED’ label.
[][]Record the cleaning parameters in the ‘Equipment Log Book.

Annexure:

Annexure I Equipment Use Log Book

Capsule Polishing Machine Set Up, Operation And Cleaning Procedure Read More »

Capsule Filling Machine Set Up, Operation and Cleaning

Production, SOPs

Capsule Filling Machine , Purpose :

Capsule Filling Machine , The purpose of this SOP is to describe the setting, operation and cleaning procedure of the Capsule Filling Machine (Model: SF-40N) in order to comply with cGMP standard.

Capsule Filling Machine , Scope :

The scope of the procedure is applicable to the Capsule Filling Machine (Model: SF-40N) at the Production area of XX Pharmaceuticals Limited.

Definitions / Abbreviation:

[][]N/A.

Responsibilities:

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

Operator

[][]Set up, operation and cleaning of the Capsule Filling Machine (Model: SF-40N)
[][]Maintaining Equipment Log Book

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 :

Safety

Special Instruction

[][]Ensure the Capsule Filling machine is properly cleaned.
[][]Compressed air pressure should be set at 6 kg/cm².
[][]Filters on the dry vacuum must be cleaned regularly. Vacuum should be used for cleaning.
[][]Do not use water or a solvent to wash filters on the vacuum.
[][]Never wash filters with water.
[][]Lubricate all moving parts as per schedule.
[][]Use correct lubricants for all moving parts.
[][]Never repair, adjust, clean or lubricate any moving parts while the machine is in motion.

Machine Assembling

[][]Open the site glass of all sides
[][]Set the desired side pusher and tighten the set screws.
[][]Set the desired race way and tighten the set screws.
[][]Set the desired feeder and tighten the set screws.
[][]Set the block and tighten the set screws.
[][]Adjust the side pusher and down pusher.
[][]Press “up” button on the display and make powder hopper in maximum height.
[][]Install the desired dose filling plate.

Adjust the dosing device.

Align the stop plate with the tamping pin holes. Insert the tamping pins and pull the stop plate to lock around the neck of the pins. Tighten the four set screws.
For alignment of dosing disk with set plate-
Loosen the dosing disk set screws.
Insert six adjustment bars through the holes on the set plate.
Adjust the position of the dosing disk until all six adjustment bars fall freely into the disk holes
[][]Tighten set screws without moving the disk.
[][]Check the alignment with six adjusting bars to see if all bars fall freely without touching the disk hole wall.
[][]Turn the machine 2-3 revolutions by the hand wheel to see the adjustment bars fall freely at all six points.
[][]Adjust the tamping pins into the set plate holes and adjust set screws.
[][]Adjust the closing pin holder and joint plate depending on the capsules size.
[][]Adjust height of dosing disk (0.5mm).
[][]Check the correct setting of change parts listed below
Upper capsule segment
Lower capsule segment
Capsule feeder
Race way
Side pusher
Capsule stopper plate
Size ring
Dose filling plate (for pellet)
Tamping pins (for powder)
Dosing disk (for powder).

Machine Operation

[][]Check the cleanliness of the filling machine. Give clearance to run the machine.
[][]Switch ON the main power switch.
[][]Open compressed air supply valve.
[][]On the control power of automatic data controller.
[][]Race machine through a few steps via the hand wheel of the main drive.
[][]Charge capsule hopper with empty capsule shell.
[][]Clear capsule locking at capsule magazine.
[][]Turn key switch MANUAL MODE to INCHING.
[][]Switch on vacuum Press the illuminated pushbutton VACUUM

Powder Station

[][]Charge powder container with powder
[][]Adjust powder height mechanical tamping pin adjustment
[][]Adjust powder filling level height on dosing disk
[][]Run machine in inch mode for 6-7 turnings until all segments are filled with capsules Press the pushbutton START Subsequent check capsule weight.
[][]If necessary, adjust the capsule weight by adjusting the tamping pin and the powder height.

Pellet Filling Station

[][]Charge pellet hopper with pellet.
[][]Open the shutter > moving it upwards
[][]Start operation of the pellet station.
[][]Run machine through several cycles in inch mode >press the pushbutton START and then check capsule weight with pellets.
[][]Let the machine running >Press the pushbutton START
[][]Check again capsule weight and correct if necessary.
[][]Start machine in automatic mode.

Control machine running

[][]Stop automatic mode > Press key STOP.
[][]Shut Off compressed air supply.
[][]Clean the machine as per current version of SOP.

Machine Cleaning

[][]Take the main switch to OFF position.
[][]Remove the pellet hopper by removing four screws.
[][]Remove pellet doser by removing four nuts.
[][]Remove the discharge chute by removing two nuts.
[][]Rotate the hand wheel, situated at the lower portion of right side of the machine, to bring capsule segment no. 1 to backside of the machine.
[][]Remove the upper capsule segment one by one by removing two nuts using allen key. Clean them with dry cloth, then tape water & finally rinse with purified water and keep them in their respective box.
[][]Remove the lower capsule segment one by one by removing two nuts using allen key from the two centering pins. Clean them with dry cloth, then tape water & finally rinse with purified water and keep them in their respective box.
[][]Loosen two set screws and remove the block of shell doser.
[][]Loosen two set screws and remove the feeder. Clean using compressed air.
[][]Loosen two set screws and remove the race way. Clean using compressed air.
[][]Loosen two set screws and remove the side pusher. Clean using compressed air.
[][]Keep the shell feeder, race way and side pusher in their respective box.
[][]Remove the capsule stopper plate by removing two nuts.
[][]Remove size ring, clean and set the desired size ring.
[][]Remove any loose powder inside the cleaning segment holes by blowing compressed air and by applying vacuum.
[][]Disassemble the upper part of the granules doser, dose controller and dose filling plate. Clean them with organic solvent like isopropyl alcohol. (For pellets).
[][]Loosen the coupling for the agitator screw and driving shaft. (For powder)
[][]Remove dust from the agitator screw, driving shaft and powder tank with clean cloth. Wash them 2-3 times with potable water then rinse with purified water. Wipe them with dry clean cloth. Allow drying in air conditioned room.
[][]Loosen the set screws and remove the fastening plate by lifting and tilting. Clean the fastening plate with cloth, then tape water & finally rinse with purified water and keep them in their respective box
[][]Loosen the set screws and remove the dosing disk and chamber. Clean the dosing disk and chamber with cloth, then tape water & finally rinse with purified water and keep them in their respective box
[][]Loosen the lock screws, turn the adjusting screws all the way up and lift the pin holder to remove thirty pins with the holder.
[][]To remove pins from the holder, loosen the set screws, pull the stop plate forward, and remove pins. Clean them with tape water & finally rinse with purified water and keep them in their respective box
[][]After final cleaning affix the ‘CLEANED’ label.
[][]Record the cleaning parameters in the ‘Equipment Log Book’

Annexure:

Annexure I Equipment Use Log Book

Capsule Filling Machine Set Up, Operation and Cleaning Read More »