We provide a range of biological sampling services to the Pharmaceutical sector, helping to ensure stringent product quality and safety standards essential to this industry.
Within this sector, facility owners need to carry out frequent clean room monitoring in production areas (for instance, sterile filling lines and solution prep areas), often as part of their quality control procedures, to check for background contamination that may have found its way into the controlled environment. As well as ensuring appropriate levels of non-contamination, documentation of regular bio sampling may also be required as part of the product’s quality control history, potentially available for inspection by others in the supply chain and by external regulators.
Bio sampling therefore has to be regular, accurate, consistent and well documented. A failure in any one of these aspects can have a serious financial and reputational impact on the business, ranging from undetected contamination (with possible consequences for consumer safety), to the need to destroy an entire batch of product, lost production time or even facility shutdown.
Due to the regularity of testing required within pharmaceutical production, microbiological sampling is often carried out in-house. Here, Tecomak’s role is typically to provide additional third party testing, perhaps quarterly or annually, to supplement and verify in-house clean room monitoring and provide documentation required by regulators (e.g. for the MHRA).
Usually, we will visit to a pre-arranged schedule agreed with each facility – but we can also provide a highly responsive, on-demand sampling service if a facility has reason to suspect contamination.
In addition to scheduled monitoring we can provide advice and consultancy to in-house staff or the facility owners. For instance, in a new facility or where new processes are being introduced, we can advise on appropriate types and frequency of biological sampling based on differing levels of risk. This might include which areas of a cleanroom to locate settle or contact plates for testing purposes, or when to use active air sampling techniques. We can also provide training for in-house staff, helping to ensure they are performing sampling correctly, in a consistent fashion and producing reliable results.
Our microbiological testing service covers the full spectrum of micro-organisms including fungi, bacteria and viruses, and encompasses both passive and active sampling techniques as required.
For contract clients we will arrange visits to suit the schedule of individual facilities, designed to minimise disruption. We also arrange automatic reminders and keep all documentation archived in physical and electronic form.