We help pharmaceutical manufacturers ensure quality, safety and the efficacy in their products

The pharmaceutical division of Microchem is a South African Health Products Regulatory Authority (SAHPRA) approved contract laboratory that specialises in the microbiological analysis of pharmaceutical products and ingredients. As part of our provision of the service we conform to current Good Manufacturing Practices (GMP).

Microbiological testing plays an important role in the production of pharmaceutical drug formulations. Pharmaceutical microbiological testing ensures that raw materials used in manufacturing match the standard quality requirements before they are processed in the production environment. Whether you need to determine sterility, preservative efficacy, microbial limits, absence of objectionable organisms, detect endotoxins, or determine environmental monitoring processes efficacy, we can assist you.

We understand that pharmaceutical manufacturers are legally responsible for the quality, safety, and efficacy of their products and to ensure that they meet the specifications to achieve the highest quality standards. This is an essential part of protecting brand integrity and providing consumer confidence. With this in mind, we test all pharmaceutical samples in accordance with the latest USP established methods.

Food Testing and Consulting

Partnering with Microchem gives you access to in-depth testing expertise, innovative testing techniques and world-class facilities and equipment, all designed to help you get your products to market faster, with the highest degree of confidence in the results.

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Endotoxin Testing:

Endotoxins are potentially toxic natural compounds from the cell wall of gram-negative bacteria. Endotoxins form part of molecules collectively known as pyrogens which can elicit high fevers in humans when it enters the bloodstream. The Limulus Amoebocyte Lysate (LAL) test is a widely used method for the detection and semi-quantitation of endotoxins in sample. This method is based on the quick clotting reaction that occurs between bacterial endotoxins and the amoebocytes (specialised blood cells) of the horseshoe crab (Limulus polyphemus). We make use of the lysates prepared from the amoebocytes to detect and semi-quantify endotoxins in test samples.

Sterility Testing:

Sterility testing is performed to ensure medical devices, pharmaceuticals, and therapeutic preparations, manufacture under sterile conditions or sterilised by appropriate means, are free from viable microorganisms that could lead to patient harm. We boast a purpose-built cleanroom laboratory, designed to minimises the potential for false positive results associated with other types of sterility testing environments so we can deliver reliable results.

We use two methods to perform sterility testing:

  • Membrane Filtration
  • Direct Inoculation
Preservative Challenge Testing (PET):
Many pharmaceuticals and cosmetics are prepared for multi dose applications. Formulations of this nature are prepared with preservatives to inhibit the growth of contaminating microorganisms during regular use. At Microchem we can perform preservative challenge testing on an array of products. The product is inoculated with a specified number of different challenge organisms. Over a period of 28 days the product is examined to determine the number of microorganisms which remain viable at specified time intervals.
Microbial Limits Testing:
For non-sterile products we perform microbial limit testing using pharmacopeial methods to determine the bioburden within a sample. We routinely conduct microbial enumerations for Total Yeast and Mould (TYMC) and Total Aerobic Microbial Count (TAMC). We also test for specified microorganisms which include Pseudomonas aeruginosa, Eschericia coli, Staphylococcus aureus, and Salmonella species.
Microchem SAHPRA Certificate

Bioburden Determination

Bioburden testing is carried out to determine the total number of viable organisms on a medical device.

Routine bioburden testing acts as a monitoring system which may alert possible production problems which could lead to inadequate sterilisation or possible product recalls. Our testing capabilities:

  • Medical devices
  • Routine monitoring for control of manufacturing processes
  • Assessment of the efficiency of cleaning processes
  • Validation and revalidation of sterilisation processes
  • Bioburden methods designed to suit each client’s needs

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We pride ourselves on customer service and value all of our customers. Please contact us for a free consultation.

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