Quality Control Testing

Bactimm performs pharmacopoeial and non-pharmacopoeial microbiological tests routinely on a large scale basis for pharmaceutical products and medical devices in compliance with GMP-GCLP.

We combine chemical and microbial product knowledge with quality control testing, method development and validation studies for finished formulations, active pharmaceutical ingredients, excipients and medical devices.

In our state-of-the-art laboratories we offer a complete range of services including chromatography facilities (HPLC, UPLC, GC, LC-MS and TLC), spectroscopy (UV and IR) dissolution testing and GMP certified class A – D cleanrooms where all microbiological investigations are carried out.

Routine quality control tests for pharmaceuticals and cosmetics include:

• Bioburden testing
• Sterility testing
• Endotoxin testing
• Antibiotics assay
• Preservatives resting

Medical device testing packages include:

• Testing of biocontainers
• Testing of sterile implants
• Accelerated ageing studies
• Sterilisation validation of gamma irradiation processes
• Particulate matter
• LAL testing

Standard throughput times vary depending on the methods used, but are on average are between eight and 17 working days. Express services can also be performed in three to five working days based on the requirement, if the methods of analysis permit.

Bactimm is currently evaluating and devising rapid analysis techniques through which the standard throughput time is reduced by three to five times. These techniques are specifically aimed at sterility testing and assays. Please contact us for more information.