Application technique of double donning sterile cleanroom gloves.pdf
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Sterile disposable gloves
for microbiological and particle monitored areas
Necessary basic requirements for cleanroom compatible, sterile disposable gloves,
depending on the specific application:
- low particle emission through appropriate washing and drying processes
(DI water, HEPA filter) - minimum length of 30 cm
- cleanroom compatible packaging (poly bags)
- powder-free
- correct documentation
(batch-related certificates of analysis, sterilization certificates and declaration of conformity)
Product recommendation based on cleanroom classes
Air cleanliness class EN ISO 14644-1
particulate monitored areas
Hygiene zones according to GMP
microbiological monitored areas
PPE
Personal protective equipment
Regulation (EU) 2016/425
Non-sterile disposable gloves
for purely particle monitored areas
Necessary basic requirements for cleanroom compatible, sterile disposable gloves,
depending on the specific application:
- low particle emission through appropriate washing and drying processes
(DI water, HEPA filter) - low ionic contamination
- minimum length of 30 cm
- cleanroom compatible packaging (poly bags)
- powder-free
- correct documentation
(batch-related certificates of analysis, sterilization certificates and declaration of conformity)
Product recommendation based on cleanroom classes
Air cleanliness class EN ISO 14644-1
particulate monitored areas
Hygiene zones according to GMP
microbiological monitored areas
PPE
Personal protective equipment
Regulation (EU) 2016/425