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:
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:
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:
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.