People are the single, greatest challenge to contamination control in a cleanroom. A human sheds ~1000 million skin cells per day, with 10% of skin shed expected to harbour microorganisms.
Cleanroom clothing can reduce ≥0.5µm particles by 50, as long as they are donned, processed and stored correctly. Use of cleanroom clothing alone is not sufficient.
The risk to a finished products sterility increases, as operator activities increase within an aseptic process. To maintain product sterility, it is crucial aseptic techniques are used at all times. These specific practices and procedures are performed under carefully controlled conditions with the goal of minimising contamination.
7 Steps to achieving a cleaner controlled environment
High standard of Personal Hygiene and Cleanliness – Ensure no jewellery or make-up is worn within your cleanroom.
Appropriate Cleanroom Clothing – Ensure the clothing and its quality is appropriate for the process and grade of the working area. Set up procedures to ensure that the garments are donned, processed and stored correctly.
Move slowly and deliberately – You shed more particles when you move too quickly. Rapid movements can create turbulence and disrupt unidirectional airflow; therefore careful movement should be followed throughout your cleanroom.
Ensure unidirectional airflow is not obstructed – The unidirectional airflow design is used to protect sterile equipment surfaces and products. Disruption in a critical area can pose a risk to product sterility.
Contact sterile materials only with sterile instruments - Between uses, sterile instruments should be maintained in a manner that prevents contamination. Instruments should be replaced as necessary throughout a process.
Cleanroom personnel training – Ensure those who work in cleanrooms understands the kind of contamination that can enter the cleanroom, being aware of these unexpected sources can help you to prevent further contamination.
Clean your Cleanroom - It is important to establish cleaning and disinfection policies and procedures that specify which cleaners and sanitisers to use, as well as areas to be cleaned and frequency of cleaning.