Over recent years there has been a growing demand for cleanroom technology in the pharmaceutical sector, due to an ever greater requirement for sterile drugs and vaccines. A research study in 2016 suggested the market for cleanroom products is set to grow steadily, with the pharmaceutical field as one of the areas where demand is highest.
Tecomak provides a comprehensive range of specialist cleanroom services, which includes inspections and checking air flow and performance, as well as installing equipment and refurbishing cleanrooms.
We also supply and install biological safety cabinets and laminar flow cabinets, which are often used in the pharma and biotech sectors. These can be used within a cleanroom setting or in some cases can provide an alternative to a full cleanroom.
Pharmaceutical Cleanroom Requirements
A recent survey predicted that, worldwide, demand for cleanroom technology will rise by more than 4% annually over the next few years. In the UK, there has been an expansion in various different types of process which need protection within the pharmaceutical industry.
These include the manufacture of medicines, ranging from liquids to tablets, capsules and powders, as well as production of vaccines and other sterile medical products. In addition to medical production, sterile conditions are also vital for areas where pharmaceutical products are packed, for instance in blister packs.
Companies operating within the pharma industry need to protect operators against being exposed to harmful chemicals and particles used in production, as well as protecting the sterility of the product.
There is also a growing need for cleanrooms in the bio-tech sector, since recent years have seen fast growth of work involving tissue and cell cultures. In this type of facility, pathogens and biological agents could be issues, creating health risks for staff members, so protection is needed against these contaminants.
Cleanroom Inspection and Regulations
Pharmaceutical cleanrooms are highly regulated, as with those in the medical sector, and are governed by a raft of regulations and standards, including ISO 14644-1. This sets a threshold for air cleanliness, with the concentration of airborne particles having to fall below a set level.
Some pharma cleanrooms will also come under HTM 03-01, a protocol governing critical ventilation in healthcare environments. These include pharmacy aseptic suites and some inspection and packing rooms where product needs to be kept sterile.
The regulations governing cleanrooms both within the pharmaceutical sector and elsewhere are constantly being updated, so it is vital to keep on top of them and choose contractors who know what the current best practice and expected standards are. Tecomak always keeps up-to-date with legislative changes.
The frequency of inspections will vary depending on the type of facility and regulatory regime, but they need to be carried out regularly to ensure the cleanroom is performing properly. Pharmacy aseptic suites are classified as critical systems under HTM 03-01, meaning they must receive an annual verification visit by qualified experts, in addition to quarterly inspections by maintenance staff.
Tecomak’s Services to Pharmaceutical Cleanrooms
Tecomak provides complete cleanroom services to the pharmaceutical sector, whether you are installing a new cleanroom, refurbishing an existing one or require maintenance, repairs or a verification visit. We have been working closely with both the pharma and biotech sectors over the past 15 years.
Our services include consultancy and guidance on cleanroom design, a full refurbishment and fitout service, and installing equipment, including specialist ventilation systems geared to the requirements of a pharmaceutical facility. We can advise you on ensuring the cleanroom air flow follows the correct direction and complies with all relevant standards. Tecomak can also supply and install biological safety cabinets and laminar flow cabinets which are appropriate for pharmaceutical use.
As well as installation, our expertise includes cleanroom testing, maintenance and validation. During inspections, the tests we carry out include airflow visualisation, in addition to testing all mechanical and electrical equipment.
As contractors, we combine cleanroom maintenance visits with inspections, which saves you both time and money and means the facility is not put out of operation for any longer than necessary. We are aware of your business priorities and work around you. Tecomak keeps full records of your facility and carries a stock of spares specifically geared to the need of your equipment, including cleanroom HEPA filter supplies. Click to find out more about Tecomak Environmental Services and our services for pharma cleanrooms.