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The Role of PPE in the Pharmaceutical Industry

01 November 2023

Health and contamination risk are of significant importance when it comes to discussing control measures in your cleanroom or controlled environment.

Many pharmaceutical companies within the industry use extremely dangerous and hazardous chemicals in their work processes, i.e. chemicals and gases. The current regulations identify 3 main categories for hazards in a workplace: physical, health and environmental hazards; PPE can play a pivotal role in keeping your workers safe from health hazards, making it fundamental for safeguarding that the appropriate PPE is worn. Studies show that 75% of all contamination within a cleanroom or controlled environment comes from staff and their clothing. This can have many repercussions such as business shutdown for cleaning and product recall.

Regulations play a huge role in safeguarding staff within a cleanroom or controlled environment and are currently evolving to ensure the most up to date level of safety. For example the final revision of the EU’s GMP Annex 1 has resulted in companies needing to make additionall requirements to eliminate and control potential risks associated with the cleanroom industry and garments. Also, COSHH (Control of Substances Hazardous to Health) states that PPE should be used as a “last line of defence when all other measures are inadequate to control exposure.”

Comfort is also an essential consideration for PPE as sweating increases particle shedding, fatigue and injuries. Cleanroom PPE must also prevent contamination. The garments that you wear must be complaint within the regulations and standard associated with the grade of your cleanroom. There are tests to validate the efficacy of PPE:

Helmke drum test – measures the particles that are generated by the garment.
PFE (Particle Filtration Efficiency) test how well the garment prevents particles shed by the wearer from escaping.

Body Box Test – Assesses particle shedding from the wearer and the garment.
At CES Ltd, we offer a wide range of PPE from face masks and gloves, to coveralls and overboots from all the biggest names in the cleanroom indsutry – DuPont™, Ansell, Micronova, Kimtech and more.


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