Why Cleanrooms Are Essential for Pharmaceutical Manufacture
The UK Pharmaceutical industry is one sector for which Airology provides cleanroom environments. We create these facilities for processes to meet MHRA requirements, giving pharmaceutical manufacturers confidence to proceed.
How Do Cleanrooms Support Pharmaceutical Production?
Cleanroom design includes air filtration, ventilation and temperature and humidity controls to restrict the amount of airborne particulate matter within a sealed area. This provides an environment appropriate for primary and secondary pharmaceutical production.
MHRA Regulations for Pharmaceutical Preparation: GMP Environments
The regulatory body for pharmaceutical manufacturing in the UK is the MHRA. Facilities producing pharmaceutical goods are required by the MHRA to ISO or GMP environments:
- Filling
- open ampoules
- sterile processes
- solution preparation
- filling products for terminal sterilisation
Cleanroom classification depends on the particulate matter per cubic metre under ISO standards or GMP grades. There are other factors such as the presence of sinks and drains, laminar airflow cabinets and whether it is at rest or in operation.
Maintaining Clean Environments
To maintain clean environments, cleanrooms employ several HVAC technologies and processes.
- Ventilation
- Fresh Air Makeup
- Positive Air Input
- Humidity & Temperature Control
Ventilation removes contaminants such as PM25s, clothing fibres and microbes through vents at the base of the cleanroom. The vented air is replaced by filtered air, brought in combined with fresh air makeup. This can be increased to positive air input to create a higher air pressure within the environment rather than in areas outside, preventing the ingress of contaminants. Humidity and temperature control are also included in cleanroom installation to reduce airborne droplet size and prevent material degradation.
Pharmaceutical cleanrooms are not a substitute for hygiene practices and must include daily sterilisation and proper practice from personnel to avoid contamination. For example, processes should be designed to avoid personnel moving between differing grades/classes of cleanroom areas.
Risks of Contamination in Improper Facilities
Where cleanroom construction does not meet appropriate standards, medicines and pharmaceutical products are compromised in their safety and efficacy. A small amount of contaminant could have deadly consequences for patients, so it is important that cleanrooms are independently validated and undergo regular testing.
Cleanroom specialists can create custom layouts around your ideal workflow and processes to make sure connections remain in one area and avoid unnecessary contamination. This adds efficiency to your processes, saving time and money.
Airology Systems’ Expertise in Cleanroom Solutions
The clear regulations around pharmaceutical and medical manufacturing ensure the safety of all consumers. We support our clients in creating a custom facility that meets the correct specifications so they can proceed with confidence and manufacture safe, high-quality products. Contact Airology to discuss your requirements.
