Viruses, bacteria and fungi can cause widespread damage in environments where a high level of cleanliness is essential. This applies to hospital operating theatres and patient isolation rooms, plus research and development labs – and the pharmaceutical industry.
Tecomak Environmental Services have been providing high-quality biological decontamination and sterilisation services for more than four decades. Here we look at five key reasons why microbiological sampling is so important for the pharmaceutical industry.
Protecting the Product
Pharmaceutical products have to be manufactured in strictly controlled conditions otherwise their quality could be compromised – and they won’t perform the medical function they were intended to.
The mass manufacture of modern-day medicine involves many different areas, such as sterile filling lines and solution prep areas, which all need to be maintained to the highest standards of safety and cleanliness, so background contamination must be stopped from entering the production chain.
Protecting the Public
The pharmaceutical industry needs to be sure that its products are ‘as advertised’ – otherwise they won’t effectively treat the condition they have been taken for. There is also the possibility that contamination will result in unwanted side-effects, given that the patients taking them may be more vulnerable to infection. It is therefore essential to reduce the risk of any contamination.
Protecting the Staff
Many pharmaceutical products are made from hazardous chemicals, and any unwanted contamination could pose a safety risk to staff working inside the lab as well as compromising the quality of the product. Even if the staff follow all the recommended guidelines – such as wearing eye and skin protection, cleaning up any spillages quickly, ad frequently washing their hands – there may still be risks, which microbiological sampling can help identify.
The pharmaceutical industry is highly regulated because of the potential risks involved. The MHRA – the Medicines and Healthcare Products Regulatory Agency – only grants licences to companies which meet the relevant quality control standards, which includes sampling. The agency makes visits to sites to check if companies are following what is known as Good Manufacturing Practice, and the distribution arrangements are monitored too.
An additional level of safety is provided by HTM 03-01, a Health Technical Memorandum governing air quality as set out by the Department of Health. In some pharmaceutical manufacturing labs, LEVs may be used to ensure the quality of the air, otherwise the product may be contaminated. In both these cases Tecomak Environmental Services can carry out all the legally-required testing.
Pharmaceutical companies may be held financially and legally liable if one of their products is released onto the market and is later found to be defective. As well as any damages they may have to pay, there will also be longer-term consequences.
Sales of other products may also be affected, even if the problem was restricted to one tablet or pill, as consumer confidence in the company will be a badly affected. The reputational damage to the company’s brand name will be huge, particularly in this age of the internet and social media.
Microbiological Sampling from Tecomak Environmental Services
Because the level of cleanliness required within the pharmaceutical industry is so high, the function of Tecomak Environmental Services is often to act as a back-up to a company’s own in-house testing procedures. We can provide regular, scheduled microbiological sampling inspections to verify the company’s own results, or make a one-off, on-demand visit if there is reason to suspect product contamination.
We also provide training and advice for the company’s in-house testers, to ensure they are recording results accurately. If you would like to learn more about our sampling services,follow this link.