Application technique of double donning sterile cleanroom gloves.pdf
DownloadSterile 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