32 validation and qualification protocols, ready to execute

Performance Qualification of Steam Sterilizer (Autoclave): Heat Distribution, Heat Penetration and Biological Indicator Challenge

To provide documented evidence that the steam sterilizer (autoclave) delivers a uniform temperature in the empty chamber and, for each validated load pattern, reaches and holds the sterilisation temperature at the coldest point of the load so that a sterility assurance level (SAL) of 10⁻⁶ is achieved consistently.

Periodic Performance Qualification of Vertical Autoclave for Media, Glassware and Discard (Decontamination) Loads

To verify, once a year and after changes, that the vertical autoclave still sterilises the routine media and glassware loads and decontaminates the discard load of the microbiology laboratory consistently within the validated parameters.

Performance Requalification of Hot Air Oven (Drying and Dry-Heat Sterilisation)

To provide documented evidence that the hot air oven used for drying of glassware and accessories and, where used, dry-heat sterilisation maintains a uniform and stable temperature within set point ±5 °C (and NLT the minimum sterilisation temperature at the coldest point for sterilisation cycles) at every location of its working space, under empty and routine loaded conditions, and that its display and alarms work as intended.

Performance Requalification of Microbiological Incubator (Temperature Mapping)

To provide documented evidence that the incubator used for incubation of microbiological media and tests maintains a uniform and stable temperature within the specified range (20 °C to 25 °C or 30 °C to 35 °C) at every location of its working space, under empty and routine loaded conditions, and that its display and alarms work as intended.

Performance Qualification of Cold Chamber (Walk-in, 2 °C to 8 °C)

To provide documented evidence that the cold chamber used for storage of media, reagents, cultures and samples at 2 °C to 8 °C maintains a uniform and stable temperature within 2 °C to 8 °C at every location of its working space, under empty and routine loaded conditions, and that its display and alarms work as intended.

Periodic Performance Qualification of Laboratory Refrigerator and Freezer

To provide documented evidence that the refrigerator / freezer used for storage of media, culture stocks, reagents and other temperature-sensitive materials maintains a uniform and stable temperature within 2 °C to 8 °C (refrigerator) and −10 °C to −20 °C (freezer) at every location of its working space, under empty and routine loaded conditions, and that its display and alarms work as intended.

Periodic Performance Qualification of Water Bath

To provide documented evidence that the water bath used for melting and holding of agar media and incubation-related activities maintains a uniform and stable temperature within set point ±2 °C (holding of molten agar: 45 °C to 50 °C) at every location of its working space, under empty and routine loaded conditions, and that its display and alarms work as intended.

Performance Qualification of Steam Pot (Media Melting / Free-Steaming)

To provide documented evidence that the steam pot used for melting of solidified agar media and free-steaming of media maintains a uniform and stable temperature within 95 °C ± 5 °C during the hold at every location of its working space, under empty and routine loaded conditions, and that its display and alarms work as intended.

Periodic Qualification of Laminar Air Flow (LAF) Unit / Unidirectional Airflow Workstation

To verify at defined intervals that the laminar air flow unit delivers unidirectional HEPA-filtered air of the required velocity, that its HEPA filter is free of leaks, and that the work zone meets Grade A (ISO 5) cleanliness, so that aseptic microbiological work done in it is protected.

Performance Qualification of Microbial Air Sampler (Impaction Type)

To provide documented evidence that the microbial air sampler aspirates the set air volume accurately, places the agar plate correctly under the sampling head, impacts the air evenly on the agar surface and runs on battery for a full monitoring session, so that active air sampling results in environmental monitoring are reliable.

Validation of Disinfectant Efficacy by Use-Dilution and Surface Challenge Tests

To demonstrate that each disinfectant and sporicidal agent used in the facility, at its in-use concentration and contact time, kills the standard test organisms and the facility's own environmental isolates on the surfaces it is used on.

Antimicrobial Effectiveness Test (Preservative Efficacy) Protocol

To demonstrate that the antimicrobial preservative system of the product reduces, or does not allow the growth of, deliberately added micro-organisms over 28 days, and to validate that the neutraliser used allows recovery of the test organisms from the product.

Method Suitability (Validation) of Microbial Enumeration Test and Tests for Specified Micro-organisms

To demonstrate that the microbial enumeration method (TAMC and TYMC) and the tests for specified micro-organisms used for a non-sterile product or raw material recover low numbers of the test organisms in the presence of the product, so that the routine results are valid even when the product has antimicrobial activity.

Method Suitability for Microbial Testing of Purified Water (Membrane Filtration on R2A Agar)

To demonstrate that the membrane filtration method on R2A agar used for routine total viable count of purified water recovers the test organisms and typical water-borne organisms, and to confirm the sample volume and incubation conditions used routinely.

Performance Qualification of HVAC System (Air Handling Unit) for Classified Areas

To provide documented evidence that the air handling unit and the areas it serves consistently meet the design air changes, HEPA integrity, differential pressure, temperature, relative humidity, airflow pattern, recovery time and cleanliness (non-viable and viable) required for their grade.

Performance Qualification of Compressed Air System (Generation and Points of Use)

To provide documented evidence that the compressed air system consistently supplies air of the specified quality (particles, water, oil, viable count and, where specified, gases) at the generation point and at every point of use, especially where the air comes into direct contact with product or product-contact surfaces.

Hold Time Study of Sterilised Glassware and Microbiological Accessories

To establish, with documented evidence, how long sterilised glassware and microbiological accessories (wrapped in their routine wrapping and stored in their routine place) remain sterile and fit for use after sterilisation.

In-Use Shelf Life (Hold Time) of Filtered 70 % IPA Solution

To establish, with documented evidence, how long filtered 70 % v/v isopropyl alcohol (IPA) prepared in-house keeps its strength, cleanliness and disinfecting efficacy when stored in its routine containers, and to assign an in-use expiry.

Efficacy of Chloroxylenol and Chlorhexidine–Cetrimide Disinfectants at Use Dilution

To select, with documented evidence, the use dilution and contact time at which the chloroxylenol (PCMX) and chlorhexidine gluconate–cetrimide disinfectants used in non-sterile areas reduce the challenge organisms on the surfaces where they are used.

Validation of the Growth Promotion Test and Stability of Working Culture Suspensions

To demonstrate that the laboratory's growth promotion test (GPT) procedure reliably shows whether each culture medium supports growth of low numbers of the test organisms and, for selective media, shows the right inhibitory and indicative properties.

Risk-Based Selection of Environmental Monitoring Locations (Air, Surfaces and Personnel)

To select and justify, with a documented risk assessment, the locations and frequencies for active air sampling, settle plates, surface samples and personnel monitoring in each classified area, and to prepare room-wise EM location layouts.

Validation of EM Methods: Settle Plate Exposure, Active Air Sampling and Incubation

To show that SCDA plates (with or without glycerol) keep their growth-promoting properties after 4 hours of settle-plate exposure and after high-volume active air sampling, without drying or cracking.

Establishment of Alert and Action Levels for Environmental Monitoring

To set alert and action levels for viable environmental monitoring (settle plates, active air, contact plates and personnel) for each grade and method from the site's own historical data, below the regulatory limits.

Shelf Life of Prepared Microbiological Media

To establish the storage period (shelf life) of prepared plates, tubes and bottles of each culture medium under defined storage conditions, by checking pH, physical condition, sterility and growth promotion over time.

Hold Time of Dehydrated Culture Media after Opening the Container

To establish how long a container of dehydrated culture medium can be used after it is first opened, by checking its physical condition and the performance of media prepared from it over time.

Rationale for Selection of Products for Microbial Method Suitability (Bracketing)

To define, with a scientific rationale, which products, strengths and batches are tested for method suitability of the microbial enumeration test and tests for specified micro-organisms, so that every product's routine test is covered without repeating equivalent studies.

Alert and Action Levels for Purified Water (TAMC, Specified Organisms and TOC)

To set alert and action levels for total aerobic microbial count (TAMC) and total organic carbon (TOC) of purified water, sampling point by sampling point, from the system's own historical data, and to define the review of specified organisms.

Hold Time of Purified Water Samples for Microbial and TOC Testing

To establish how long purified water samples can be held between sampling and testing, and under which conditions, without changing the microbial count or the TOC result.

Environmental Monitoring Qualification of Corridors and Non-Processing Areas

To establish, with data over three consecutive working days, the microbial cleanliness of corridors, airlocks and other non-processing areas of the production block, and to set routine monitoring locations and frequency for them.

Microbiological Qualification of RLAF (Sampling / Dispensing Booth) and Dynamic Pass Box

To demonstrate, after installation or modification, that the reverse laminar air flow (RLAF) units used for sampling and dispensing of materials and the dynamic pass boxes deliver the expected microbial cleanliness in their work zones.

Verification of Ready-to-Use Quantitative Culture Pellets against Laboratory-Prepared Cultures

To verify that ready-to-use lyophilised quantitative culture pellets give counts within the certificate value, are pure and correctly identified, and can be held after rehydration for the period claimed, so that they can replace laboratory-prepared inocula in GPT and method suitability.

Bioburden of Primary Packaging Materials (Swab, Rinse and Direct Methods)

To establish a validated method (swab, rinse or direct immersion, with membrane filtration) and baseline bioburden for each type of primary packaging material, and to set limits and a monitoring frequency.