SOPs

Waste Management in Quality Control Laboratory

Waste Management; Purpose

The purpose of this SOP is to describe the laboratory waste management procedure for disposal of test samples (raw materials, in-process, bulk/ finished product left over samples); expired retention samples (raw materials, finished product); broken glassware and glass container; packaging materials; all Laboratory chemicals & reagents used within the quality control laboratory.

Waste Management; Scope

This procedure is applicable to all laboratory operations associated with the disposal activity in the quality control and microbiology laboratory for general block at XX Pharmaceuticals Limited.

Definitions / Abbreviation
  • SOP: Standard Operating Procedure
  • QC: Quality Control
  • ETP: Effluent Treatment Plant
  • MSDS: Material Safety Data Sheet
Responsibilities

The roles and responsibilities are as follows

Senior Executive/Executive, QC & Microbiology
  • To ensure that this procedure is followed.
  • To identify correct sample for disposal.
 Asst. Manager, Quality Control
  • To ensure that this procedure is kept up to date.
  • To confirm that the SOP reflects the required working practices.
  • Arrange training on the SOP to all concerned personnel.
  • To ensure implementation of the SOP into routine use after training.
  • To ensure availability of adequate facilities, systems and resources to carry out this process and approve the SOP.
Head of Quality Assurance
  • Take initiative to Approval of this SOP
  • To ensure the overall implementation of the SOP
Procedure
  • Wear rubber gloves, mask, safety glass and footwear during disposal work.
  • Carry out the disposal work at the designated place.
  • Wash hands thoroughly with soap and water, at the end of the operation.
  • Always keep the waste bin covered with lids.
  • Destroy any label/carton/ foil before dumping into the bin for disposal.
  • Cross mark all label on the container with marker pen or destroy the label of container before disposal.
  • Use separate container for collecting the broken glass and transfer to the salvage yard-marking container as “BROKEN GLASSWARE”.
  • Do not return left over samples of raw materials, in-process material, bulk/ filled products to the container or work points from which it has been taken.
  • Keep all the waste in designated bin.
  • Carefully identify the name and check the status label of the sample to be disposed off.
  • Check the MSDS of raw materials for the hazardous identification and proper method of disposal.
  • Check the container properly for any left out material before disposition of the containers.
  • Use the sink of fume cupboard to drain out flammable, toxic, corrosive water-soluble solvent and all mobile phase.
  • Never light any type of flames & always place sign “No Flames” to warn others about the presence of Ether. Accumulate water immiscible solvents [like Chloroform, Dichloromethane, Carbon Tetrachloride, etc.) into one bottle & ether (Diethyl Ether waste) in another bottle & evaporate them separately using beaker by placing in fume cupboard.
  • Place hazardous solid waste (e.g. tissue paper, filter paper, cotton, contaminated gloves etc.) in dedicated bin/container.
  • Dispose liquid samples in sink by using large amount of tap water.
  • After completion of test, retain left over samples of raw materials, in-process material, bulk/ finished products with proper identification labeled as “UNDER TEST SAMPLE” in specified place the batch is approved.
  • After approval of the batch, transfer the excess samples (tablets, raw materials, capsules) of approved batch to a place labeled as “SAMPLE FOR DISPOSAL” record the disposal details in the Sample Disposal Register (Annexure-I).
  • Once in a month or when required, collect and destroy all samples for disposal following the above steps.
  • In case of raw materials, in-process material, and bulk/ finished products, empty out the sample from the poly bag into a container containing water, destroy the sample label of poly bag by shredding into “WASTE BIN FOR PAPER” & destroy the ploy bag in to the bin, labeled as “HAZARDOUS SOLID WASTE “.
  • Shake dispersion of sample in container with the help of a glass & allow disintegrating. After the complete disintegration, drain out slowly into designated place & clean the drain with adequate water flushing.
  • For stability sample after approval of report, analyst shall destroy the samples by dispersing them into a container having sufficient water and destroy the film, foil, de-blistered strips/blisters into a designated bin, labeled as “FILM/ FOILS FOR DISPOSAL”;
  • The secondary packaging materials (carton, leaflets, labels, shipper carton, master carton) into “WASTE BIN FOR PAPER” and other packaging materials (i.e. polyethylene bag, cap, plastic stopper, dropper etc.) into another bin, labeled as “PACKAGING MATERIAL FOR DISPOSAL”.
  • Shake the dispersion of sample in container with the help of a glass rod and allow to disintegrate. After complete disintegration, drain out slowly into designated place and clean the drain with adequate water flushing.
  • In case of ampoules, vials and bottles; break open the glass ampoule, open the vials and bottles, empty the contents in water and discard the broken ampoule and vial into a bin, labeled as “BROKEN GLASSWARE”. Shake the dispersion of sample in container with the help of a glass rod and allow to disintegrate. After the complete disintegration, drain out slowly into designated place and clean the drain with adequate water flushing.
  • Collect all types of waste from the respective bins into the different polythene bag by attaching “TO BE DISPOSED” label, weigh the waste content, and send waste to the salvage yard with a waste transfer note.

Download Annexure Here: Waste Management

Annexure I Sample Disposal Register

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Test solution and volumetric solution Preparation & standardization

Test solution and volumetric solution; Purpose

The tenacity of this procedure is to describe procedure for preparation & handling of test solution and volumetric solution.

Test solution and volumetric solution; Scope

This SOP is valid for preparation of chemical reagent in Quality Control Laboratory at XX Pharmaceuticals Ltd.

Definitions

N/A

Responsibilities

The roles and responsibility is as follows

Officer/Executive/ Sr. Executive, Quality Control
  • To confirm tests are performed with correct reagent as specified in method.
  • To confirm record of reagent preparation in the work sheet.
  • To confirm correct storage of reagent.
  • To confirm use of reagent within the shelf life.
  • To confirm reagents are retained until test results are approved.
  • To confirm use of log book.
Assistant Manager, Quality Control
  • To ensure reagents are in place and controlled.
  • To assess & disposition of expired reagent.
  • To maintain record.
  • To incorporate sound technical knowledge.
Head of Quality Assurance
  • To ensure the overall implementation of the SOP.
  • Take initiative to approval of the SOP.
Procedure

Precaution(s):

  • Wear protective clothing, gloves and goggles. Avoid contact with skin, eyes & clothing & inhalation of vapor.
  • Use a fume hood while preparing solutions.
  • Read label instructions of reagent container for any special precaution.
General
  • For solution preparation use purified water & analytical grade reagents & chemicals.
  • Prepare solution as per respective approved worksheet.
  • Calculate expiry date of solutions from date of preparation.
  • Check the following things before preparation of any solution.
  1. Glassware being used is clean & dried.
  2. Required reagents are available.
  3. Required instruments are calibrated.
  • Wear suitable safety appliances while making concentrated solutions of acid & alkali/any hazardous chemicals/substances.
 General guideline for the preparation of Test Solution
  • Enter details in test solution preparation register (as per Annexure-I)
  • Assign sequential reference number as below:
  1. g.TS-001/09/XX
  2. Where, TS is the abbreviation of Test Solution
  3. 001 is the sequential number
  4. / is separator
  5. 09 is the month of preparation (September)
  6. XX is last two digits of year 20XX
  • Affix respective label on container as per Annexure-III.
  • Expiry date of test solutions will be 06 months or as per mentioned in respective worksheet. During usage, any change in physical properties of the solution identified then discard it.
  • If a solution is directed to prepare “fresh” then it must be prepared on the same day of use
  • Discard the excess solution after expiry/ usage by diluting the solution with doubled quantity of water & then drain it into the drainage, and & entry on the respective worksheet & register.
General guideline for the preparation of volumetric solution
  • Analyst shall prepare all type of volumetric solutions as per respective worksheet.
  • Enter details in volumetric solution preparation register (as per Annexure-II)
  • Assign sequential reference number as below:
  1. g.VS001-001/08/XX
  2. Where, VS001 is the code no. of 0.1 M Ammonium thiocyanate VS
  3. 001 is the sequential number
  4. / is separator
  5. 09 is the month of preparation (August)
  6. XX is last two digits of year 20XX
  • Affix respective label on the container as per Annexure-IV.
  • Volumetric solutions and standard solution for limit test must not be store for more than three months. If during usage any change in physical properties of the solution identified then discard the solution.
  • Where stabilization time is not mentioned, stabilize solution for one hour before standardization.
  • Carry out standardization & calculate factor of the solution twice & RSD of two results must be within 0.2%
  • Find out the mean factor, which will be within ±5.0% of the labeled factor.
  • If factor of prepared solution identified more than ±5.0% variation, do the necessary dilutions/weight adjustments and carry out re-standardization. Report the factor upto four digits after decimal.
  • Solution should be re-standardized in 1 month +7 days interval. In case, where extraneous matters, layer separation or hazy solution observed then discard the solution.
Assign re-standardization reference number as below

e.g. Reference No./R1

Where, Reference No. of the volumetric solution subjected to re-standardization

/ is separator

R1 is re-standardization for first time (e.g. R1, R2…..)

Store all the solutions in cleaned dry containers & use amber color containers for light sensitive solutions.

Reject excess solution after expiry/ usage by diluting the solution with doubled quantity of water and then drain it into the drainage, and make entry on the respective worksheet & specific register.

Download all Annexure Here

Annexure I Test Solution Preparation Register

Annexure II Volumetric Solution Preparation and Standardization Register

Annexure III & IV Label for Test Solution & Label for Volumetric Solutions

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Chemicals and Reagents Management in Quality Control Laboratory

Chemicals and Reagents Management; Purpose

The tenacity of this SOP is to define the process for order, receipt, labeling, daily issue, stock control, handling, storage, labeling and expiry dating of all laboratory chemicals and reagents, solvents & solutions used within the quality control laboratory at XX Pharmaceuticals Ltd.

Chemicals and Reagents Management; Scope

This procedure is applicable to all laboratory chemicals & reagents, solvents & solutions used in the quality control laboratory at XX Pharmaceuticals Limited.

Chemicals and Reagents Management; Definitions / Abbreviation

[] ACS: American Chemical Society.

[] AR: Analytical Reagent.

[] GR: Guaranteed reagent.

[] MSDS: Material safety data sheet.

[] SOP: Standard Operating Procedure.

[] QC: Quality Control.

 

Reagent

Reagent is a substance which is added to a system in order to cause a specific chemical reaction, or added to notice if a reaction occurs or not.

Flash point

It is describe as minimum temperature of liquid at which it provides sufficient vapor to form ignitable mixture with the air.

Flammable liquid

Any liquid having Flash Point below 37.8⁰C[100 F]. Less-flammable liquids having flashpoint between 100 F & 200 F are well-defined as the combustible liquids.

HLF:

Highly flammable liquid having Flash Point of less than 32⁰C

Corrosive substance

A corrosive substance can be defined as which destroy or irretrievably damage human tissue when it comes into contact. Normally used corrosives are: Ammonium Hhydroxide, Acetic Acid, Chromic Acid, Hydrochloric Acid, Hydrotropic Acid, Hydrofluoric Acid, Nitric Acid, Perchloric Acid, Potassium Hydroxide, Phosphoric Acid, Sulfuric acid, Sodium Hydroxide.

YTD

Year-to-date. It can be defined as a period, starting from the beginning of the current year, and continuing up to the present day.

Chemicals and Reagents Management; Responsibilities:

The roles and responsibility is as follows

Officer/ Executive, QC
  • To raise requisition for & receive all laboratory chemicals & reagents maintaining proper procedure.
  • To confirm labeling with proper information, expiry dating of all laboratory chemicals, solvents, reagents and solutions after receipt or preparation.
  • To maintain daily issue, usage & all records properly as per SOP.
  • To confirm that procedures are followed during preparation of reagents & solutions.
  • To confirm that this procedure is followed.
Manager, Quality Control
  • To confirm that this procedure is kept up to date.
  • To check that the SOP reflects the required working practices.
  • To conduct training on the SOP to all concerned personnel & ensure implementation after training.
  • To confirm effective assessment for expiry dating of laboratory chemicals, reagents and solvents.
  • To track timely procurement of laboratory chemicals and reagents.
Manager, Quality Assurance
  • Take initiative to Approval of the SOP.
  • To confirm the overall implementation of the SOP.

Procedure:

Precaution(s):
  • Follow the relevant MSDS & safety guidelines while handling chemicals & hazardous reagents.
  • Proper protective clothing such as safety glasses, gloves & laboratory coat must be worn while handling chemicals in the laboratory.
  • Use fume hood while handling acids, bases, hazardous & flammables substances.
  • Try to minimum exposure to avoid contamination.
  • Use sonication to degas HPLC mobile phase before use.
  • Correctly label each unit container of chemicals & reagents.
  • Read reagent label very carefully before any type of use.
  • Don’t use any chemical or solvent when contaminated or change of physical appearance or precipitation observed.
  • Never ingest toxic substances.
  • Do not allow highly flammable liquids, toxic substances, corrosive substances to come into contact with the skin and eye.
  • Keep away flammables substances from fire or ignition source.
General guidelines
  • Never use beakers or measuring cylinders for precise volumetric measurement.
  • Always use class a glassware for all volumetric application.
  • Allow solutions temperature reduce to room temperature before any dilution to volume.
  • Always use clean, inert PTFE stirring bar as magnetic stirrer.
  • Reagent quality must be ACS[American Chemical Society] or AR or GR grade or equivalent, unless otherwise specified in relevant analytical method.
  • To prepare reagent solutions always use distilled water or purified water (that complies with USP/ BP/ EP requirement).
  • To avoid contamination even with best precaution, never return dispensed chemicals to stock bottle.
  • Before mixing solutions together, measure each solution individually.
  • Highly consumable like Methanol, maintain control of first in first out (FIFO) process.
  • Checked Expiry dates of reagent solution be before use.
  • To prevent contamination to the entire quantity and allocate the same expiry date as mentioned in the primary container, divide a large quantity of reagent into smaller containers. This is very useful for hygroscopic reagents.
  • Light sensitive reagent solution is to be kept in plastic bottles or amber glass.
  • Store chemicals in a designated place, away from heat or sunlight, return to the same location after each time of use.
  • Never store chemicals or waste in fume hood.
Ordering of reagents and chemicals
  • Review laboratory chemicals & reagents stock inventory on Monthly/Six monthly/Yearly basis / as when required.
  • Prepare a list for purchasing of new reagents & chemicals to ensure uninterrupted analysis in laboratory operations.
Raise a purchase requisition considering the following elements:
  • New method related to new product which is in product launching pipeline for commercialization of new product.
  • Reagents or chemicals with short self life expiry.
  • Pharmacopoeia (BP, USP & EP) requirements.
  • If possible, to avoid powder handling, Order toxic materials in liquid form.
  • Place requisition minimum three months earlier to the Procurement Department before the existing stock become nil.
Receipt of reagents and chemicals
  • Just after receipt, check integrity of the container & ensure reagents & chemicals are received its standard condition.
  • Check label on the bottle & tally with invoice / certificate / MSDS. If any discrepancy is found, report promptly to Store and Procurement Department.
  • After receipt, record receiving information at “Reagent and Chemical Receiving Register” as per Annexure-II & “Reagent Stock and Issue Register” for Liquid/Solid as per Annexure-III respectively.
  • Use ‘S- serial number’ for solid reagent & L- serial number’ for liquid reagent for reagent code numbering,.
  • Affix a reagent label to each unit primary container as per Annexure-VI.
  • Record the date of receipt & storage temperature mentioned on the label collected from manufacturer’s label/ certificate of analysis/ invoice. Assign the expiry date if found in manufacturer’s label.
  • Allocate the expiry date from the date of opening as follows, unless otherwise stated in manufacturer’s label,
  • Store reagents & chemicals in dedicated area where temperature at or below 30°C.
  • Keep large quantities solvents in the solvent store at room temperature unless otherwise stated in manufacturer’s label.

 

Chemicals and Reagents Management

 

Use of reagents and chemicals
  • Issue unbroken bottle/container from stock against requisition as per Annexure-I & maintain issue record (issued quantity/ issued by/date/balance amount etc. as required) into the ‘Reagent Stock and Issue Register’ for Liquid or Solid as per Annexure-III.
  • On the basis of critical stock position, raise requisition for chemicals & reagents to procurement department.
  • Allocate opened date/expiry date sign on the previously affixed label for newly opened container.
  • Not issued bottle/containers must not be mix with the opened bottle/container.
 Handling and storage of Toxic substances, highly flammable liquids

Toxic substances:

  • All toxic substances/chemicals to be labeled as toxic & handled under fume cupboard.
  • For weighing dry toxic powder, use container with lid. Add approximate amount of powder to the container & close lid in a fume hood. Back to the balance & weigh the powder. Back to the fume hood to prepare solution.
  • Keep container closed as soon as possible with tightly fitting.
  • Low dilute solution (<1% w/v) of toxic substances may be handled in the laboratory with appropriate care to avoid contamination of the area & individuals.
  • All vessels/containers used for long-lasting storage of toxic substances/chemicals must be carefully labeled with the contents & hazard type.
  • Vinyl/nitrile/latex gloves must be worn while handling toxic substances/chemicals. Properly fitted mask must be use to handle handling solid toxic substances.
  • Adequate care should be taken during removing of PPE [Personal Protective Equipment] to avoid contamination of the hand/face.
  • All contamination by toxic substances/chemicals must be washed off/cleaned up instantly as per instructions/guidelines/protective measures mentioned on MSDS [Material Safety Data Sheet].
  • Disposal of toxic substances/chemicals must be conduct with extra care.
 Highly flammable liquids
  • Majority of laboratory solvents and certain flavors, essence & film coating solutions are highly flammable liquids

can cause serious fires & explosions with subsequent injury to personnel & damage to goods.

  • Must be stored in the isolated place of Solvent store area.
  • An intact bottle shall be transferred to the laboratory by maintaining a record/requisition.
  • Stored quantity in the Laboratory/ Production area must not exceed 20 litres.
  • To avoid accumulation of vapor, must be stored in a suitable well ventilated place.
  • Must be handled in a well-ventilated area such as a fume cupboard in the Laboratory.
  • A suitable carrier to be use during carrying of Bottles to minimize the risk of breakage.
  • Containers should not store in direct sunlight/near a source of heat/ignition. Store the containers in the isolated place on a metal/solvent resistant tray.
  • Never use in the same working area near undressed flame, hot plate/any equipment that is legally responsible to produce a spark.
  • Container must be closed at all times other than when the liquid is being transferred from it.
Download all Annexure Here: Chemicals and Reagents Management

Annexure I Requisition Form for Laboratory Chemicals and Reagents

Annexure II Reagent and Chemical Receiving Register

Annexure III Reagent Stock and Issue Register

Annexure IV List of Toxic Laboratory Chemicals

Annexure V List of Flammable Solvents

Annexure VI Label for Reagent

 

 

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Handling of spillage in quality control laboratory

Handling of spillage; Purpose

The tenacity of this SOP is to define the handling of the spillages in the quality control laboratory to make laboratory safe, neat & clean.

Handling of spillage; Scope

This process is applicable to the chemical room, instrument room in the quality control laboratory of XX Pharmaceuticals Limited.

Definitions / Abbreviation:

[] MSDS: Material Safety Data Sheet

[] SOP: Standard Operating Procedure

[] QC: Quality Control

[] Spillage: The act of allowing a fluid or material to escape from the container.

Responsibilities

The roles and responsibility is as follows.

Lab attendant, QC

[] To clean-up the spills maintaining proper procedure.

Officer, QC

[] To ensure that this procedure is followed.

Manager, Quality Control
  • To confirm that this process is kept up to date.
  • To confirm that the SOP is reflects the required working practices.
  • Place training on the SOP to all concerned personnel.
  • To confirm implementation of the SOP after training.
Head of Quality Assurance
  • Take initiative to Approval of this SOP.
  • To confirm the overall implementation of the SOP.

 Procedure:

Precaution(s):
  • Carefully handle the solvents & chemicals to avoid accidents & spillages.
  • Use gloves, mask & eye protector while handling spillage.
  • Be watchful while neutralization process of acid or base spills because it may be enthusiastic, cause splashes & yield large amount of heat.
  • For spillage of flammable liquids, control all potential source of ignition near spillage area.
  • Never generate dust or cause the contaminated powder to become airborne while cleaning of solid spills.
  • If broken glass is involved, never pick it up with gloved hand rather than use tongs.
  • Ensure that all forms of local exhaust i.e. fume hoods are operating.
  • Water shouldn’t be used for chemicals which are water reactive.
  • Never use a vacuum cleaner to clean up the spill.
  • On spillage, personnel who caused the spill will instantly inform supervisor, all persons in the laboratory to take care & the lab attendant to clean spillage.
  • Evacuate the specific area, if required.
  • Limit access to spill area until total cleanup is completed.
  • For water spillage use only mop with dry cloth.
  • Wear suitable PPE[personal protective equipment] e.g. gloves, goggles, masks etc. while cleaning up spills.
  • Use tongs to pick-up the broken glass, when spills involve broken glass, place it in plastic dustpan to place them in the bin dedicated for broken glassware.
  • Use brush & the plastic dustpan to place materials into polyethylene bags & dispose it as chemical waste when spillage of solids.
  • If spillage occurs due to liquids like acids or solvents, mop it up clearly.
  • When needed, add adequate quantity of absorbent silica or precalcinated silica granules and let stand for few minutes, collect the material using hand gloves into polyethylene bags & dispose it as chemical waste.
  • If needed, use sodium bicarbonate to neutralize acids. Use pH paper to check pH when acid spills have been neutralized. Then mop it up with water.
  • For spillage of liquids like alkali, add adequate quantity of water to dilute it, mop with the help of dry cloth and finally wipe with wet cloth.
  • In case of Mercury spills, begin cleanup procedure with collecting the droplets of mercury. The large droplets can be consolidated by using scraper or a piece of cardboard. For cleaning up small mercury droplets, pick up with a piece of adhesive tape. Slowly & carefully squeeze mercury onto a damp paper towel. Place paper towel into polyethylene bags & dispose it as chemical waste.
  • While cleaning the area where spillage of hazardous chemicals & poisonous take precautions as per MSDS of respective chemicals.
  • After bulk of the material is cleaned up, wipe up the area with previously mixed detergent water & then with tap water and then leave the area to dry.
  • Rinse tools (plastic dustpan, tongs etc.) off plentiful amount of water.
  • Dry tools off & keep in isolated place.
  • Dispose of gloves as waste and place goggles back into the dedicated area.

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Chemical laboratory safety procedure, how to maintain it?

Chemical laboratory safety procedure; Purpose

Chemical laboratory safety procedure, The tenacity of this SOP is to define the general laboratory safety procedure, which will confirm the safe working condition within the Quality Control Laboratory.

Chemical laboratory safety procedure; Scope

This practice is valid for laboratory operations in the quality control laboratory of XX Pharmaceuticals Limited.

Definition

[] MSDS: Material safety data sheet.

[] PPE: Personal protective equipment.

[] QC: Quality Control.

[] SOP: Standard Operating Procedure.

Responsibilities:

The roles and responsibility is as follows

User/Analyst

[] To use personal PPE [Protective Equipment] as per MSDS [Material safety data sheet].

[] To maintain appropriate procedure for safety.

Manager, Quality Control
  • To confirm that this procedure is kept up to date.
  • To check that SOP reflects required working practices.
  • To organize training on the SOP to all concerned personnel.
  • To confirm implementation of the SOP after training.
  • To achieve the operational control.
  • To confirm the availability of suitable PPE & safety equipment.
Head of Quality Assurance
  • Take initiative to Approval of the SOP.
  • To confirm the overall implementation of the SOP.

Procedure:

Precaution(s):

  • Take a note of material hazard facts from the supplier’s information. Review any relevant hazard data in MSDS.
  • Do not smoke, drink, chew gum, eat, or apply cosmetics in the laboratory.
  • Do not keep food or beverages in the laboratory.
  • Always keep the flammable chemicals away from sources of fire.
  • Try to avoid unnecessary chemical exposure.
  • Never use fume hood for storage.
General procedure
  • Wear laboratory coat and dedicated laboratory shoes, before entering into the laboratory. Keep goggles/ eye protector in the pocket of lab coat and & when necessary. This will give protection against corrosive action of chemicals & contaminations.
  • Check PPE prior to use & attire appropriate protective equipment as processes dictate & when required to avoid chemical exposure.
  • Wear gloves when using any type of hazardous or toxic chemicals & respirator when handling solvents.
  • Wash & clean gloves regularly during a hazardous job. Discard soiled gloves as hazardous waste after use. Remove them before leaving laboratory/at the end of the work.
  • When handling/transferring solid chemicals only from one container to another, wear gloves dust mask and activity to be perform under fume cupboard.
  • Treat anonymous chemicals as hazardous & before starting work, make sure the analysts are familiar with all known hazards of the chemicals & take proper precautions.
  • Reject glass apparatus that is damaged, cracked/even scratched.
  • Examine all glassware before use. Use washed & clean glassware. Always move gas cylinder on cylinder trolley. Gas cylinder when standing upright position should always be appropriately supported.
  • Use fume hood to handle hazardous chemicals, volatile liquid and flammable compounds.
  • If solvent extraction is perform by shaking in a separating funnel, release pressure at frequent intervals by reversing funnel. Point the funnel away from the eyes & naked flames.
  • Avoid pipetting anything by mouth. Use mechanical pipetting device/pipette bulb/ aspirator.
  • Always add the acid to the water when diluting acids; never add water to acid. Add the acid to water slowly.
  • Conduct periodical inspection in laboratory refrigerators & storerooms, correctly label all collected samples.
  • Confirm all electrical wires are properly insulated. Report all electrical faults to the reporting authority/supervisor.
  • Instantly Report all type accidents to the Supervisor/Manager.
  • Confirm that all personnel engage laboratory know about the fire exit from the chemical laboratory.
  • Confirm eye showers & Fire extinguishers are located at easily accessible points.
  • Confirm all personnel/user are aware about the locations & proper use of all safety equipments (e.g. eye shower, First-aid kit, fire extinguishers).
  • Wash hands before leaving the laboratory, in case of chemical handling.
  • Wash the exposed area with large amount of water in case of spillage of any acid, base or irritant material on skin and seek immediate medical support if required.
  • Clearly sealed& labeled the dangerous materials and never leave it on the working bench unattended
  • Visitors to laboratory should be under the direct supervision of a accountable personnel.
Spillages
  • Spillages must be instantly dealt as per SOP for Handling of Spillages in the QC Laboratory.
Disposal of waste
  • Waste must be disposed as per SOP for Waste Management in QC Laboratory.

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Air Borne Particle Counter Operation

Air Borne Particle Counter; Purpose

To describe a standard operation, Cleaning & Calibration procedure of Air Borne Particle Counter.

Air Borne Particle Counter; Scope

Procedure is applicable to Air Borne Particle Counter of at XX Pharmaceuticals Limited.

Definition/Abbreviation:

Particle counter: An analytical device to count non-viable particles of specific sizes.

IPA : Isopropyl Alcohol.

Responsibilities:

The roles and responsibility is as follows:

Microbiologist

[] Follow the instructions of this procedure correctly.

Asst. Manager, Microbiology/QC

[] Ensure that SOP is technically sound & reflects the required working practices.

[] Confirm this procedure is kept up to date

Head of Quality Assurance

[] Take initiative to Approval of SOP.

Procedure

Instructions

[] Never use IPA on the display to wash it.

[] Don’t let the verification filter to be moistened.

[] Use your finger dab directly, don’t uses your nail on touch screen.

Operation
  • Turn on power switch.
  • Press “CONFIG” for “DATA SETUP”.
  • Select particle size with pressing “PARTICLE” option.
  • Select the particle size for another date setup then Press” BACK “option
  • Press ” SAMPLE” option for delay time, sampling time, sampling volume and no. of cycle setup then pressing “ENTER” for saving input.
  • To go to main display, Press ” BACK” option.
  • For manual mode or automatic mode, Press “SETTING”
  • For counting the particle, Press the “START” option.
  • Depending on room size, calculate number of sample.
  • Go to main the display
  • Press “CONFIG “
  • Pressing” LOCATION” option, Select Location.
  • Press” EDIT “option, if required to add new location.
  • To go to main display, Press the “BACK” option.
Set Location & Recipe
  • Go to the main display
  • Select the “CONFIG” option
  • Select the “RECIPE” option
  • Select the location
  • Write location name
  • Select the particle size
  • Select sampling time & sampling volume
  • Write down desired volume.
  • Select delay & set delay time (Initial one is 05 second by default).
  • Enable print average if needed
  • Select Auto print (if needed)
  • To go to main display Press “BACK” option.
  • Top count the particle, Press the “START”.
  • Completion of counting cycle is stopped automatically.
  • Then press “START” option for another cycle & counting the particle.
  • Take Print When Auto print option is disable
  • Go to the Main Display.
  • Press “DATA” option
  • Press” RANGE” option
  • Pressing “MAIN” option, Go to main display
Verification Test( Zero Count Test)
  • Go to the Main Display
  • Click on the Sampling Button
  • Select the location (Location should be 5)
  • Write Zero count test
  • Select time (1minute)
  • Select Unit( Ft ³ )
  • Select the Zero count test
  • Select the Sample
Cleaning

[] Clean Air Borne Particle Counter with & pipe with a piece of clean cloth

[] Use 70% sterile IPA damped cloth to clean it.

[] Clean the Display only with a clean sterile dry cloth.

Calibration Procedure

[] Contact with the supplier to the equipment to calibrate as per schedule.

[] Perform the calibration yearly or as per supplier instructions.

Download Annexure Here

 Annexure I Air borne particle Counter Logbook

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Water Bath, Operation, Calibration and Cleaning

Water Bath; Purpose

The tenacity of this SOP is to define the operation, calibration & cleaning of Water Bath

Water Bath; Scope

This procedure is applicable for Water Bath installed in Microbiology section at XX Pharmaceuticals Limited.

Definitions/Abbreviations

LED: Light Emitting Diode

Responsibilities:

The roles and responsibility are as follows

Executive/Senior Executive, Microbiology
  • To confirm that the instructions of this procedure are properly followed.
  • To maintain the record correctly as per SOP.
  • To confirm cleaning of shaking water bath maintaining safety guidelines.
Assistant Manager, Microbiology
  • To confirm that this process is kept up to date.
  • To ensure that the SOP is technically sound & reflects required working practices.
  • To arrange training on the SOP to all concerned personnel & to ensure implementation of the SOP after training.
  • Schedule calibration of the instrument at the defined intervals.
Procedure
Instructions
  • Laboratory coat, hand gloves & safety glasses must be worn while handling instrument.
  • Never touch the liquid within the bath as it may be very hot.
  • Each time use the display or a thermometer to check the temperature.
  • Never block ventilation slots during operation.
  • Each time disconnect bath from electricity supply before cleaning.
  • Allow the liquid in bath to cool down to 40°C before draining.
  • Use only purified water, never operate water bath without water.
  • Fill the it prior to connection to power supply.
  • It should be covered with a lid or polypropylene spheres to achieve optimum performance.
  • Always use the stainless steel flat lid with concentric rings when the instrument is not in use to avoid contaminants landing in the bath liquid.
  • Don’t touch any electrical contacts or open any closure panel that may be risk of electrical shock when above 60˚C or below room temperature,
Operating Procedure
  • Check the calibration date of the instrument before each time use. If the calibration is out of date, calibrate it and then use.
  • Check water level, If require adjust the water bath to an appropriate level with purified water.
  • Switch on the power from the main.
  • Using the switch “I” ON, “O” OFF button located at the rear side of it, Switch on the Water bath When ON (I) the switch is illuminated & unit performs a self-test where all segments of the 3 digit LED display & indicators illuminated.
  • To display “SP1” to set temperature, press & hold down key for more than 1.5 seconds. “SP1” will show blinking.
  • To select required temperature, use up or down arrow keys.
  • Heater indicator will illuminate. Wait until the display flashes between “SP1” & set temperature and will revert to show actual liquid temperature.
  • When the bath temperature is either 4°C above or below set temperature, LED indicator will illuminate.
  • Open concentric ring & place beaker or suitable container with sample on sphere of it.
  • After completion of work, switch off bath by using “I” ON, “O” OFF switch, located at rear side of back of it.
Calibration Procedure
  • Calibrate Water bath once in a year.
  • Fill purified water in water bath to an suitable level.
  • Switch on the bath using “I” ON, “O” OFF switch, located at the rear side of back of the Water bath.
  • Set desired temperature against calibrated standard thermometer at 35⁰C, 45⁰C, 65⁰C.
  • Wait 30 minutes to equilibrate.
  • Verify temperature using a calibrated standard thermometer & record the temperature in the Calibration information sheet for Water bath (as per Annexure-I).
Cleaning Procedure
  • When water becomes dirty, clean instrument otherwise clean once in a week.
  • Switch ‘OFF’ the instrument.
  • Disconnect main power supply.
  • Open stainless steel flat lids with concentric rings of the water bath.
  • Use purified water to wash the stainless steel flat lids and concentric rings.
  • To reduce potential biological contamination, remove the water from water bath.
  • Wash it with soapy water & then purified water.
  • Mop with clean dry cotton cloth.
  • To remove any deposits, use 10% nitric acid on a cloth (wear suitable gloves).
  • Gently heat to 50°C for an hour after adding 1 liter of vinegar to water in the stainless steel tank, empty and brush the lime away for descaling then rinse thoroughly afterwards.
  • Fill with purified water up to desired level .
  • Close the stainless steel flat lids with concentric rings.

 Download Annexure Here

Annexure I Calibration Information Sheet for Water Bath

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Cooled incubator, Operation, cleaning and calibration procedure

Cooled incubator Purpose

To operate, clean and calibrate Cooled Incubator in order to support the growth of Yeast and mould in Microbiological analysis.

Cooled incubator Scope

This SOP applies for operation, cleaning and calibration of Cooled Incubator, Model: ICP600 in Microbiology Section of at XX Pharmaceuticals Limited.

Definitions/Abbreviations

N/A

Responsibilities

The roles and responsibility is as follows

Executive/ Senior Executive, Microbiology

Operation, cleaning & calibration

Assistant Manager, Microbiology

Ensure Operation, cleaning, calibration and application of sound information.

Head Quality Assurance

Take initiate to approval of SOP

Procedure:

Instructions

  • Do not wipe with damped cloth at on position.
  • Use only 70% IPA or ethanol to wipe chamber
  • Do not overload chamber with tested items.
  • Do not keep items those may produce inflammation with air.
  • Keep all tested items to avoid touch inner surface of the chamber.
  • Do not move the Cooled Incubator at on position. Severe vibrations may cause serious damage of the temperature probes.
Operating Procedure
  • Press push/turn control key to put on main power switch in front of instrument. The Cooled Incubator will start in normal mode with display of timer, chamber temperature, alarm temperature (red color indication).
  • Hold down SET key & turn the push/turn control key at the clockwise or anti clockwise for setting date, local time, operating temperature at [23.5± 2.5]0C, alarm temperature at 300 After setting, SET key will be released the display briefly flashes the set point. The display then changes to the actual current temperature and starts to the setting temperature. The temperature will be automatically increased at setting temperature and display the setting temperature digitally.
  • Observe the display temperature until stable position.
  • Hold down the SET key (approximately 3 seconds) to select the operation mode, if require. The current operating mode will be flashed on the display. There are three operating mode in the Cooled Incubator:
  • Normal Operation
  • Weekly Programmer
  • Ramp time Programme Operation
  • Select required programme and set as per operation manual.
  • Select fan speed to set air changes. Selected position of fan speed will show in display.
  • Turn the push/turn control at clockwise until fan symbol flashing to move the air slider opens and closes the air valve to control the supply and discharge of air.
  • Check chamber temperature using by a calibrated digital thermometer, when the setting Temperature reaches.
  • Keep the required materials inside the chamber.
Cleaning & Disinfection :
  • Switch off Cooled Incubator and disconnect the power plug.
  • Remove all test flasks and others items from chamber.
  • Clean inside of chamber initially with dry cloth and wipe finally with 70% IPA wetted cloth.
  • Clean outside of chamber with dry cloth.
  • Disinfect all surfaces with 5% Savlon solution and dry the outer surface.
  • Reload all items into chamber when reach to dry the chamber surface.
  • At the end of cleaning, connect the power plug and switch on.
  • Clean the chamber once in a month.
  • Clean the outer surface every day.
 Performance Check
  • Check chamber temperature daily once.
  • Record chamber temperature in Daily temperature Record
  • Temperature range ± 2.5C from the set temperature.
Calibration of Cooled Incubator
  • Insert standard thermometer or thermocouples into chamber.
  • Place at different location of chamber at least 6 position.
  • Press & hold down SET key until the normal mode light blinking.
  • Turn push/turn control key clock wise to reach SETUP light.
  • Select Calibration to rotate push/turn control key.
  • Use three calibration temperatures as below :
  • 1 : 150C
  • 2 : 220C
  • 3 : 300C
  • Select required calibration temperature in SETUP key & set the corresponding calibration correction to 0.00
  • Measure deviation from selected calibration temperature under the steady conditions, using a reference instrument.
  • Set calibration correction in SETUP key. If the measured reference temperature is too low, the calibration correction setting is negative sign.
  • Adjust temperature if require from adjusting value of calibration temperature (CAL). The correction value should not more than ±10C.
  • Carry out check measurement using the reference thermometer.
  • Carry out others two calibration temperatures in the same manner.
  • Calibrate the incubator once in a year ± 15 days.
  • Record calibration in Calibration Record, as per Annexure-V of Engineering SOP
 Maintenance
  • If Cooled Incubator shows any mechanical, electrical or any others problem, inform to supplier or Engineering Department for corrective action.
  • After corrective action, recalibrate Cooled Incubator.

Download Annexure Here

Annexure I Cooled Incubator Operation Log Book

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Oven Operation, cleaning and calibration procedure

Oven Purpose

To dry all properly cleaned glassware which is subject to use in chemical analysis & also to sterilize cleaned glassware which is subject to use in different microbiological analysis.

Oven Scope

This SOP applied for operation of Oven, which model is: UNE600 in QC Section, Microbiology Section & Product Development Section of at XX Pharmaceuticals Limited.

Definition/Abbreviation

N/A

Responsibilities

The roles and responsibility is as follows

Executive, Microbiology/ Executive, QC

Operation, cleaning & disinfection and performance checking of oven.

Assistant Manager, Microbiology
  • Ensure Operation, cleaning & disinfection and performance checking.
  • Ensure that oven is calibrated.
  • Checking that SOP is technically informative.
Head of Quality Assurance

Take initiative to Approval of SOP

Procedure
Instructions
  • Never enter open hands in the chamber of oven.
  • To keep or remove glassware, wear temperature resistance gloves.
  • Avoid to keep glassware into chamber with water or any other solution.
  • Do not dry plastic materials using oven.
  • Always keep door closed & avoid opening door for long period.
Operating Procedure
Sterilization of Glassware for Microbiological Analysis
  • To put on the main power switch, Press push/turn control key in front of the instrument. Oven will start in normal mode with the display of the chamber temperature, timer, alarm temperature.
  • Turn the push/turn control key by hold down the SET key & at the clockwise or anti clockwise for setting date, local time, operating temperature, alarm temperature. After setting, SET key will be released the display briefly flashes the set point.
  • To select the programme, Press & hold down SET key and rotate push/turn control key at clockwise and select “Ramp timer” mode.
  • Set the work days group using the push/turn control by holding down the SET key and Press push/turn control to select the ramp segment “t1” If the day is not required, it will be off position.
  • Set the time using push/turn control by hold down the set key &
  • Use the push/turn control, to Select ramp segment “t2”. Hold down SET key and using the push/turn control set the time.
  • Until the temperature display is flashing, Turn push/turn control clockwise. Set the required temperature setpoint using push/turn control
  • Select setpoint waiting time by hold down the SET key. Hold down SET key and set on using the push/turn control. After the SET key has been released the function for setpoint waiting time is stored.
  • Hold down SET key & set time using the push/turn control then Select hold time “t3”.
  • Hold down SET key & set time using push/turn control after selecting cooling time “t4”.
  • Select program repeats “loop”. Hold down the SET key and set 2 for repeats using the push/turn control.
  • To set the air changes, select the fan speed. Turn the push/turn control clockwise until the fan symbol is flashing. Set fan speed 50% suing the push/turn control holding down the SET key.
  • Turn the push/turn control clockwise until monitor temperature display is flashing. Set the alarm temperature using the push/turn control holding down the SET key & select alarm temperature.
  • Turn push/turn control at clockwise until the fan symbol flashing to move the air slider opens & closes the air valve to control the supply and discharge of air.
  • Turn the push/turn control clockwise until the stop symbol ▀  is flashing. Select start ► using the push/turn control holding down the SET key and On releasing the SET key the program starts to run
Glassware Drying
  • To put on main power switch. Press push/turn control key in front of the instrument. The oven will start in normal mode with display of chamber temperature, timer, alarm temperature.
  • Select operating mode “Normal operation” holding down SET key (approximately 3 seconds) the current operating is flashing.
  • Select temperature set point by hold down the SET key & use the push/turn control to select required temperature set point. After the SET key has been released the oven briefly flashes the temperature setpoint. Heating is indicated by the orange heater symbol.
  • Select fan speed. Turn push/turn control clockwise until fan symbol is flashing while the holding down the SET key. To set 50% fan speed use the push/turn control
  • Turn the push/turn control clockwise until the monitor temperature display is flashing. Select the alarm temperature. Use the push/turn control to set the alarm temperature by holding down the SET key.
  • The display then changes to the actual current temperature and starts to the setting temperature. The temperature will be automatically increased at setting temperature and display the setting temperature digitally.
  • Observe the display temperature until stable position.
  • Remove dried glassware from oven at the end of drying,
Cleaning of Oven
  • Clean the inner benches of Oven with a cleaned cloth.
  • Use 70% IPA or ethanol to disinfect the inner surfaces.
  • Clean the outer surfaces with dry cleaned cloth.
  • Disinfect the outer surfaces with 5% Dettol /Savlon solution.
Calibration of Oven
  • Insert standard thermocouples or thermometer into the chamber.
  • At least 6 position to be consider to place different location of chamber.
  • Press & hold down SET key until the normal mode light blinking.
  • To reach SETUP light, turn push/turn control key clock wise.
  • Select Calibration to rotate push/turn control key.
  • Use the following temperature for calibration:
  • 1 : 1500C
  • 2 : 2000C
  • 3 : 2500C
  • Select required calibration temperature in SETUP key & set the corresponding calibration correction to 0.00
  • Under the steady conditions, using a reference instrument, measure the deviation from the selected calibration temperature.
  • If the measured reference temperature is too low, the calibration correction setting is negative sign, set the calibration correction in SETUP key.
  • The correction value should not more than ±10C.
  • Adjust the temperature if require from adjusting value of calibration temperature (CAL), carry out the check measurement using the reference thermometer.
  • Carry out others two calibration temperatures in the same manner.
  • Calibrate incubator once in a year.
  • Record calibration in Oven Calibration Record, Annexure-II.

Maintenance

Inform to supplier or Engineering Department for maintenance, If Oven shows any mechanical, electrical or any others problem, after maintenance, recalibrate the oven.

Download all Annexure here

Annexure I Oven Calibration Record

Annexure II Oven Log Book

 

 

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Vortex Mixer; Operation and Cleaning Procedure

Vortex Mixer; Purpose

To establish the procedure for ideal operation and cleaning of Vortex Mixer, Model: Genius 3 KIA, Fisher Scientific, UK in microbiology test.

Vortex Mixer; Scope

This SOP applies for operation, cleaning of Vortex Mixer, Model: Genius 3 KIA, Fisher Scientific, UK in Microbiology Section at XX Pharmaceuticals Limited.

Definitions/Abbreviations

NA

Responsibilities

The roles and responsibility is as follows:

Executive/ Senior Executive, Microbiology

Operate & clean of Vortex Mixer.

Asst. Manager, Microbiology

  • Ensure Operation, cleaning & application of sound technical information.
  • Keep the up to date of SOP.
  • Review that SOP is technically informative.
Head of Quality Assurance

Take initiative to Approval of SOP

Procedure:
Instructions
  • Do not press hardly on platform.
  • To avoid movement during vortex, keep Vortex Mixer in a fixed place.
  • Do not vortex any materials for long time.
  • To avoid overflow during vortex, maintain the level of test solution into test tube/Vial/test flask.
 Operation Procedure
  • Switch ON the power button. The red indicator light will be illuminated.
  • Press SET switch to select the automatic vortex or manual vortex.
  • Set time to press TIMER button as per requirement.
  • Adjust vortex speed by turning SPEED button at clockwise for increasing or anti clockwise for decreasing.
  • Place test tube/vial/test flask on the platform.
  • Attach tube/vial with the machine for more than 1 minute vortex.
  • Press START button if set manual vortex.
  • Touch test tube/vial on platform to start the vortex automatically.
  • Remove test tube at the end of vortex.
  • Switch OFF power button.
  • Disconnect machine.
  • Press MAINS switch off.
Cleaning Procedure
  • Switch off Vortex Mixer and disconnect the power plug.
  • Clean outer surface with dry cloth.
  • Disinfect outer surfaces of Microscope with 5% Dettol/Savlon solution.
  • Clean daily once.

Maintenance

Inform to supplier or Engineering Department for repairing, If Colony counter shows any mechanical, electrical or any others problem.

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