Microbiology

Microbiological testing services for the quality control of pharmaceutical products, raw materials, and manufacturing environments.

Microbiological testing is a critical quality and safety requirement throughout the pharmaceutical manufacturing process. From the control of microbial bioburden in non-sterile products to sterility assurance for parenteral products, as well as water testing, environmental monitoring, preservative efficacy testing, and cleaning validation, pharmaceutical microbiology encompasses a broad range of analyses that are essential to ensuring patient safety and regulatory compliance.

AMSbiopharma provides a comprehensive portfolio of microbiological testing services validated in accordance with European Pharmacopoeia (Ph. Eur.), United States Pharmacopeia (USP) methods, and applicable Good Manufacturing Practice (GMP) requirements. Our services address the key microbiological testing needs of active pharmaceutical ingredients (APIs), drug products, excipients, raw materials, and manufacturing environments. All testing is performed under controlled documentation systems by qualified personnel, generating data suitable for regulatory submissions and batch release activities.

Our catalog of services include

Metabolomics applications

Microbial Enumeration Testing (TAMC, TYMC)

Microbial enumeration testing of non-sterile pharmaceutical products is a fundamental requirement for ensuring product quality and patient safety. Determination of the Total Aerobic Microbial Count (TAMC) and the Total Yeast and Mould Count (TYMC) provides the quantitative evidence required to demonstrate compliance with the microbiological acceptance criteria established in the applicable pharmacopoeial specifications, confirming that the microbial bioburden remains within acceptable limits throughout the product’s shelf life.

AMSbiopharma performs validated TAMC and TYMC testing in accordance with Ph. Eur. 2.6.12/2.6.13 and USP <61>/<62>, including the method suitability studies required for each product type and matrix. All testing is carried out under controlled laboratory conditions by qualified personnel following documented procedures aligned with Good Manufacturing Practice (GMP) principles.

Method validation includes assessment of method suitability for each product type, incorporating the recovery studies required by Ph. Eur. 2.6.12/2.6.13 and USP <61>/<62>. Test results are provided with comprehensive supporting documentation suitable for batch release and stability programmes.

Key analytical capabilities

  • Total Aerobic Microbial Count (TAMC) in accordance with Ph. Eur. 2.6.12 and USP <61> 
  • Total Yeast and Mould Count (TYMC) in accordance with Ph. Eur. 2.6.13 and USP <62> 
  • Testing of active pharmaceutical ingredients (APIs), drug products, excipients, and raw materials

Microbiological testing of water is a critical component of the quality assurance system in pharmaceutical manufacturing facilities. The microbiological quality of water used during manufacturing—including Purified Water (PW), Water for Injection (WFI), and Highly Purified Water (HPW)—is a critical quality attribute that must be routinely monitored in accordance with the requirements of the Ph. Eur., the USP, and applicable GMP guidelines.

AMSbiopharma provides microbiological testing services for pharmaceutical water using methods compliant with applicable pharmacopoeial and regulatory requirements. Our services include microbial enumeration testing (TAMC/TYMC) and the detection of specified microorganisms, in accordance with the water quality specifications established by the Ph. Eur. and the USP for each pharmaceutical water grade.

Key analytical capabilities

  • Microbiological testing of Purified Water (PW), Water for Injection (WFI), and Highly Purified Water (HPW) 
  • TAMC/TYMC determination and detection of specified microorganisms in pharmaceutical water in accordance with Ph. Eur. and USP requirements

Antimicrobial preservatives are critical formulation components in many multidose pharmaceutical products, including ophthalmic, parenteral, oral, and topical preparations. Demonstrating preservative efficacy—its ability to prevent microbial proliferation and maintain the microbiological integrity of the product throughout its intended storage and in-use period—is a mandatory regulatory requirement that must be assessed using Antimicrobial Preservative Effectiveness Testing (AET) in accordance with applicable pharmacopoeial methods.

AMSbiopharma performs Antimicrobial Preservative Effectiveness Testing (AET) in compliance with Ph. Eur. 5.1.3 and USP <51>, using the pharmacopoeia-required challenge panel of bacteria, yeasts, and moulds, and applying the acceptance criteria established for each product category. All studies are conducted using certified reference strains under controlled laboratory conditions, with comprehensive documentation suitable for inclusion in regulatory submissions.

Key analytical capabilities

  • Antimicrobial Preservative Effectiveness Testing (AET) in accordance with Ph. Eur. 5.1.3 and USP <51>

The quantification of biological indicators and specific microorganisms is an essential component of a wide range of pharmaceutical microbiology applications, including sterilisation process qualification and validation, pre-sterilisation bioburden determination, and the monitoring of manufacturing processes where control of specific microorganisms is critical to product quality and patient safety.

AMSbiopharma provides biological indicator quantification and microorganism enumeration services using validated methods tailored to each specific application. Biological indicators are microorganisms with a defined and characterised resistance to the sterilisation process under evaluation—typically Geobacillus stearothermophilus spores for steam sterilisation and Bacillus atrophaeus spores for ethylene oxide sterilisation. Their quantification before and after the sterilisation process provides documented evidence of sterilisation process effectiveness.

Key analytical capabilities

  • Pre-sterilisation bioburden determination in accordance with Ph. Eur. 2.6.12 and ISO 11737-1 
  • Enumeration of specific microorganisms in product and process samples

Bacterial endotoxins are lipopolysaccharides (LPS) found in the outer membrane of Gram-negative bacteria. When introduced into the body through parenteral products, they can trigger severe pyrogenic reactions and, in extreme cases, septic shock. Consequently, bacterial endotoxin testing is a critical quality attribute for all parenteral pharmaceutical products and a mandatory requirement for batch release.

Key analytical capabilities

  • Bacterial Endotoxins Testing (BET) using the Limulus Amebocyte Lysate (LAL) method in accordance with Ph. Eur. 2.6.14 and USP <85>