Validation of sealers
Laminate bags in hospitals and pharmaceutical companies must be carefully sealed to maintain a product’s sterility. To demonstrate that the sealing equipment for laminate bags is functioning correctly, it needs to be periodically validated.
For the validation of sealers, our validation experts take into account the following standards: NEN-EN 868-5 and NEN-EN ISO 11607-2.
VALIDATION PROCESS
Sealers are indispensable devices in central sterilization. They are used daily to seal (laminate) bags using high temperature to melt the plastic onto the paper.
How is the validation of a sealer conducted?
Identification of the sealer and the used sealing bags
Verification of parameters after the sealer’s operation
- Continuity of the seal
- Uniformity of the seal
- Seal strength
- Conformity of the seal (the plastic is adhered to the paper)
Contact us for more information
Agidens has over 25 years of experience in validation & compliance and is a well-known name in the hospital world. Our clients trust us because of our expertise and ‘no nonsense’ approach, and with reliable service, we are a long-term partner.
