Trusted Experts in Microbial Controls, Biomaterial Design and CRO Services

Growth Promotion Testing Controls

Pharmacopoeias created quite the challenge when they designed the growth promotion test (GPT). Inoculate with less than 100 CFU, make sure strains are no more than 5 passages, incubate with specific temperatures and times, verify results are comparable to previously approved media, and perform this required test for each new batch of media. While these strict GPT requirements may intimidate some, savvy microbiologists know the power of using Microbiologics test-ready, quantitative microbial controls to simplify and accelerate their processes without compromising accuracy.

Our GPT microbial controls support your compliance with Pharmacopeia requirement including:

• Tests for Burkholderia Cepacia Complex - USP <60>
• Microbial Enumeration Tests - USP <61> | PH. EUR. 2.6.12 | JP 4.05, I.3
• Tests for Specified Microorganisms - USP <62> | PH. EUR. 2.6.13 | JP 4.05, II.2
• Sterility Testing - USP <71> | PH. EUR. 2.6.1 | JP 4.06, 3.02

Method Suitability Testing Controls

Antimicrobial and preservative ingredients used to keep products safe can also interfere with the detection of potential microbial contaminants during product release testing. To address this challenge, Pharmacopeias include guidelines for Method Suitability Testing, which is designed to confirm if antimicrobial activity in products would impact recovery of microorganism, impacting microbiological product safety. Our quantitative and user-friendly microbial controls help laboratories conduct Method Suitability Tests simply and reliably.

Antimicrobial Effectiveness Testing Controls

Antimicrobial and preservative efficacy testing (AET/PET) is critical to ensuring the microbiological safety of pharmaceutical and personal care products. It’s also a requirement of meeting USP/Ph. Eur./JP and ISO 11930 standards. The basic test involves adding a set number of microorganisms to the product and then, at specific intervals, performing an assay to determine how many microorganisms remain in it. We created our EZ-PEC™ quantitative microbial controls as a simple solution that saves laboratories time and resources while meeting Pharmacopeia standards and other guidelines.

Disinfectant Efficacy Testing Controls

Disinfectant Efficacy Testing or Disinfectant Validation Studies are necessary for demonstrating that cleaning, disinfecting and sanitizing agents and procedures are effective in inactivating or eliminating contaminating microorganisms from surfaces and components in manufacturing environments. Because manufacturing environments, surface types and potential contaminants vary greatly, there are many nuances for designing and performing a thorough disinfectant study. Microbiologics offers the challenge microorganisms laboratories need for Disinfectant Efficacy Testing in simple, reliable formats.

Mycoplasma Testing Controls

As the use of cell lines to produce biopharmaceuticals continues to increase, Mycoplasma testing is a growing quality control challenge. Because of its unique properties, Mycoplasma poses many challenges for detection and management. Mycoplasma contamination can spread quickly, yet common quality control methods can be time-consuming and complicated. To alleviate these challenges and simplify compliance with USP <63> and Ph. Eur.2.6.7, Microbiologics offers test-ready Enumerated Mycoplasma microbial controls.

Pharmaceutical Water Testing Controls

Water is widely used in a variety of ways throughout the development, manufacture and analysis of pharmaceutical products and control of microbiological water quality is important for many of those uses. Though the USP monographs for Purified Water and Water Injection do not include microbial requirements, the informational chapter <1231> states that “users should establish their own quantitative microbial Specifications suited to their water uses.” Microbiologics offers quantitative microbial controls designed to simplify water QC and help labs meet regulations and standards.