Microbiology Testing

The Antimicrobial Effectiveness Test (AET)—also called the preservative effectiveness test—is performed to demonstrate if added preservatives, or the inherent antimicrobial properties of a product, are effective.

Antimicrobial effectiveness testing is required for all multidose products and single dose products with added preservatives. Capzer Pharmaceuticals conducts the AET test and the recovery method suitability as required by USP <51>.

For the AET test, aliquots of the product are inoculated with the five challenge organisms defined in USP <51> at high populations. The samples are stored at 20-25°C for 28 days and are analyzed periodically to determine the change in challenge organism population. Additional challenge organisms can be used at the client’s request.

Bioburden testing determines the population of viable microorganisms in or on a pharmaceutical product, medical device, or component prior to sterilization. Capzer Pharmaceuticals has methods in place to perform microbial bioburden testing in accordance with ISO 11737-1:2018, “Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products.”

Capzer can also test according to client-defined methods or according to USP <61><62> when appropriate. Our industry veterans have experience testing a wide variety of pharmaceutical dosage forms, medical devices and combination products.

Our microbiologists work directly with the client to determine the appropriate sample preparation and extraction procedures to ensure the bioburden test results meet our client’s requirements.

Capzer Pharmaceuticals offers a comprehensive range of analytical services to support the validation of pharmaceutical facilities. Our analytical testing services provide support for the validation of purified water systems, clean steam systems, compressed gases and clean rooms. We can help our clients’ commission new facilities, perform on-going qualification services as well as decommission existing facilities. All of this work is performed in strict compliance to cGMP requirements following USP. We have extensive experience in purified water testing, clean steam testing, USP purified water system validation, DI water system validation, compressed gas testing and clean room testing.

The facility validation support services that we provide for Purified Water Systems and for Clean Steam Systems are:

• TOC
• Conductivity
• pH
• Calcium
• CO 2
• Sulfate
• Ammonia
• Ammonium
• Nitrite
• Nitrate
• Hardness
• Iron
• Manganese
• Chromium
• Residue on Evaporation
• Heavy Metals
• Oxidizable Substances
• Potassium Permangenate Reducing Substances
• Microbial Limits
• Endotoxins
• Particulates
• Sterility

The facility validation support services that we provide for Clean Rooms are:

• Particles – Airborne (0.3 mm – 5 mm)
• Surface Swabs – TOC
• Surface Swabs – Microorganisms
• Contact Plates
• Airborne Microorganisms – Settling Plates
• Airborne Microorganisms – Active Samplers (RCS)

Capzer Pharmaceuticals brings years of experience performing all types of analytical testing on many drug substances, drug products and medical devices. We bring the highest level of quality and attention to detail to our clients to assure that their microbial identification testing will be successfully executed.

We are FDA registered, DEA registered, cGMP compliant and ISO/IEC 17025 accredited.

Capzer Pharmaceuticals provides environmental monitoring (EM) testing services for the pharmaceutical, biopharmaceutical and medical device industries.

Clients contract us for facility monitoring services when commissioning new facilities, after facility remediation events, after planned shut downs, and during routine ongoing manufacturing. Environmental monitoring is performed to demonstrate that the systems used to control the microbiological quality of manufacturing environments are working as expected.

Excursions from established alert and action levels indicate the environmental systems may be drifting out of a state of control. Our service starts with client consultation to determine testing needs. We can perform testing to determine the viable population on surfaces, as well as the total particulates and viable particulates in air and compressed gasses. Capzer has experienced and well-trained personnel who are available to execute the on-site sampling. Capzer can also supply the necessary materials and instructions for the client to perform their own sampling and send the samples to Capzer for incubation and enumeration.

Capzer Pharmaceuticals provides clients with a comprehensive range of analytical services to support the validation of pharmaceutical facilities. Our analytical testing services provide support for the validation of purified water systems, clean steam systems, compressed gases and clean rooms. We can help our clients’ commission new facilities, perform on-going qualification services as well as decommission existing facilities.

All of this work is performed in strict compliance to cGMP requirement. We experience in purified water testing, clean steam testing, USP purified water system validation, DI water system validation, compressed gas testing and clean room testing.