We offer a range of biological sampling services for GMP and HTM 03-01 compliance, aimed at detecting and measuring the presence of microbiological contaminants including viruses, bacteria and fungi. Our service includes:

  • Viable environmental testing using settle plates, contact plates and active air sampling techniques
  • Incubation, identification and reporting of sampled microbiological media
  • Total Viable Count tests for non-sterile product
  • Consultancy services including commissioning documentation (PQ) and execution
  • GMP training support
  • Sterility testing

Facilities Requiring Biological Sampling

All facilities which need to be compliant with GMP and HTM 03-01 standards will require sampling to be carried out as part of the validation process and at other times. These can include:

  • Healthcare facilities where sterile conditions are essential to protect patients or staff, such as operating theatres, isolation units, intensive care units, neonatal incubation units and so on.
  • Pharmaceutical production facilities where the purity of the product is essential.
  • Research facilities where contamination could pose a safety risk to workers or compromise experimental data.

When is Biological Sampling Required?

Biological sampling can be required at a number of key points in the lifecycle of a clean room or other sterile facility. These times include the following:

  • As part of annual verification testing necessary for compliance.
  • When there is a suspected infection or contamination issue – perhaps as a precursor to decontamination.
  • As part of the commissioning process before first use.
  • Following plant refurbishment or the introduction of new equipment or facilities into the clean room.
  • Following duct work cleaning, to check that the cleaning process has not introduced biological contaminants into the rest of the room.

The Importance of Accurate Sampling

It is important that sampling is performed in a specific and controlled way, according to consistently administered protocols. As well as ensuring consistency of results between different facilities, you want results that you can rely on, allowing you to make the right decisions affecting the running of your facility.

This level of consistency can only be achieved by ensuring that sampling is carried out by staff with the appropriate training in microbiological sampling techniques. Tecomak carry out microbiological sampling for thousands of facilities every year, ensuring a high level of consistency and accuracy.

Where in-house staff need to carry out additional sampling as part of your ongoing monitoring requirements, is it likewise essential that these staff have the right training and support. As part of our service Tecomak can provide your staff with the necessary training as well as ongoing access to our own sampling experts.