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Cleanroom Packaging Film for Pharma: How We Keep PE Film Production Clean
Designing and maintaining cleanrooms is vital in industries such as pharmaceuticals and medical device packaging, where contamination control is fundamental to product quality and safety.
Achieving ISO 14644-1 Class 9 cleanliness requires a system that keeps contamination under strict control and meets the requirements of the ISO 14644-1 standard. To produce polyethylene films – including cleanroom packaging film used by pharmaceutical companies – we had to design and maintain clean areas that fully comply with this standard. In this article, we summarise the steps we took to create the cleanroom needed to produce polyethylene film.
Design and specification for cleanroom packaging film
Our first step was to define the required cleanliness level – and the pharmaceutical industry sets strict requirements here. For ISO Class 9, this means no more than 35,200,000 particles (0.5 microns or larger) per cubic metre of air. We then specified the appropriate air handling systems and filters, airflow patterns and materials to minimise the risk of contamination.
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Construction and build-out
During construction of the cleanroom, we took great care to ensure that neither the building materials nor the work processes would introduce additional contamination. Minimising dust generation was a top priority throughout the build – mainly achieved by selecting building materials that inherently generate little dust.
Validation and testing
After construction, the cleanroom underwent thorough testing to verify that it meets the requirements of ISO 14644-1. In this phase, we carried out particle counts and checked temperature and humidity conditions.
Maintenance and monitoring
Once validated, cleanrooms require continuous maintenance and monitoring to preserve their high level of cleanliness. This includes regular cleaning, filter replacement and maintenance of the air handling systems. To maintain ISO Class 9 conditions, we check air cleanliness regularly.
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Training our staff
Educating and training the staff who work in our cleanroom is critical, as people are the biggest source of contamination. Appropriate workwear, rules of conduct and strict adherence to cleanliness protocols are essential.
These steps ensure that our cleanroom meets the requirements of ISO 14644-1 Class 9 and that we can provide the clean environment needed to produce polyethylene film. Meeting this ISO standard not only improves the quality of our products but also raises the level of service we provide to our customers.
Films produced this way can support high-quality production in both the pharmaceutical industry and medical device packaging.