Aseptic facilities are one of the cornerstones of this country’s pharmaceutical industry as well as many healthcare environments. Here we explain the differences between ‘aseptic’ and sterile’, and why aseptic facilities require the Health Technical Memorandum (HTM) 03-01 validation services which we can provide.

Aseptic and Sterile

The two terms are often used interchangeably, even though they have slightly different meanings. Aseptic is defined as “a surface, object, product or environment which is free from contamination.” This means bacteria, viruses and other potentially harmful micro-organisms cannot survive or reproduce. The term is generally used to refer to medical (or pharmaceutical) processes which keep an environment in its sterile state. Aseptic techniques don’t create a sterile state, but they will maintain pre-existing sterility.

If something is described as sterile then it is completely free of all microscopic organisms (not necessarily just harmful ones). The term is more usually applied to specific items of medical equipment, such as needles and scalpels, or to items of packaging which are important in both pharmaceutical production facilities and hospital operating theatres.

Examples of Aseptic Environments

The following are examples of aseptic facilities:

• Food processing units (particularly liquid products such as milk, fruit juices and yoghurts)
• Pharmaceutical production units (the product, its packaging and any storage areas all need to be sterile)
• Hospital in-house pharmacies and clean rooms.

Aseptic techniques are also used in operating theatres, surgical clinics (for example, where wounds are dressed) and outpatients departments.

HTM 03-01 Validation from Tecomak Environmental Services

All aseptic facilities, whether they are primarily commercial or in a healthcare environment, do have a common denominator – all need to maintain extremely high standards of cleanliness and hygiene. In healthcare settings, failure to do so could put patients and staff at risk; in pharmaceutical and biotech labs, the product could be compromised and could ultimately result in the patient or consumer becoming vulnerable to infection too.

All of the locations listed above are subject to HTM 03-01 validation, which is where Tecomak Environmental Services can help. One of the key potential sources of infection or contamination in any aseptic facility is the ventilation system (known as a ‘critical’ system because of the sensitive environment).

In accordance with the requirements of the Memorandum, we will ensure all of the system’s filters and ducts are operating properly and in line with the manufacturers’ standards, and there are no leaks from any part of the system. (For more information about our HEPA filter testing, click here.)

We will also monitor the air pressure and air change rates, which will ensure the air flows correctly from clean to less clean areas and that the doors and windows can all be securely closed so that no potential airborne contaminants can enter the facility from outside. Diffusers and pressure stabilisers also form part of the checks.

Once all these requirements have been met, we can then issue the HTM 03-01 validation certificate. If there are any problems, we endeavour to sort them on the spot (we always carry spare filters with us, for instance) rather than organising a separate visit.

Tecomak can carry out validation testing once a year, which is the maximum interval stipulated by the Memorandum, or more frequently if needed. If you would like to know more about our HTM 03-01 services, follow this link (there’s also a form you can complete on the right hand-side of the page) or call us on 01732 852250.