- STORE
- >
- VALIDATION PROTOCOLS
- >
- Bar Sealer Operational Qualification OQ Protocol | Medical Device
Bar Sealer Operational Qualification OQ Protocol | Medical Device
- FDA QSR Compliant
- MDR EU 2017/745 Compliant
- ISO 11607-1/2:2019 Compliant
- ASTM F88, F1886 and 1928 Compliant
- MS Word Format
- Digital Content - Instant Download
Bar Sealer Operational Qualification ProtocolOur Bar Sealer Operational Qualification (OQ) Protocol is used to qualify equipment and operating parameters used for the sealing of sterile packaging materials (i.e. Tyvek/Mylar, Foil, PA/PE, Paper/Mylar Pouches, etc.) sealed with any make or model bar sealer.
Bar Sealer Operational Qualification Protocol Content OverviewThe protocol specifies the manufacturing conditions, controls, testing, and required acceptance criteria. The qualification protocol includes the following elements:
RELATED LINKS Bar Seal Qualification Protocol Bundle (OQ and PQ) Tray Seal Qualification Protocols Bundle (OQ and PQ) 4 Sided Seal Qualification Protocol Bundle (OQ and PQ) Product Stability Shelf Life Procedure Accelerated Aging Study |
Fundamental Qualification Considerations
The three critical operating parameters, common to any make or model sealing machine, are: Temperature, Time and Pressure. (In the case of conveyor fed sealing machines these parameters may translate to Temperature, Speed and Gap). A prerequisite for qualification activity is gaining an understanding of the appropriate settings to be used to seal the materials selected. Input from packaging suppliers, preliminary testing such as Design of Experiments and/or Edge of Failure Analysis will help dial in the parameters used during the qualification process. |
Customer's also viewed
Bar Sealer Performance Qualification PQ Protocol | Medical Device
Our Bar Sealer Performance Qualification (PQ) Protocol is a comprehensive 17 page document developed specifically to address regulatory requirements for qualifying medical device bar sealing equipment/process used to seal sterile medical device packaging. The Bar Sealer Performance Qualification (PQ) Protocol is structured in accordance with ISO 11607 and FDA QSR Requirements.
- FDA QSR Compliant
- MDR EU 2017/745 Compliant
- ISO 11607-1/2:2019 Compliant
- ASTM F88, F1886 and 1928 Compliant
- MS Word Format
- Digital Content - Instant Download
Bar Sealer Qualification Protocols Bundle OQ - PQ | Medical Device
- FDA QSR Compliant
- MDR EU 2017/745 Compliant
- ISO 11607-1/2:2019 Compliant
- ASTM F88, F1886 and 1928 Compliant
- MS Word Format
- Digital Content - Instant Download
Tray Sealer Qualification Protocols Bundle OQ - PQ | Medical Device
Tray Sealer Operational Qualification (OQ) and Performance Qualification (PQ) Protocol Bundle product includes a Tray Sealer OQ and a PQ Protocol. Each protocol is a comprehensive 17 page document developed specifically to address regulatory requirements for qualifying medical device tray sealing equipment/process used to seal sterile medical device packaging. The Tray Sealer OQ and PQ Protocols are structured in accordance with ISO 11607 and FDA QSR Requirements.
- FDA QSR Compliant
- MDR EU 2017/745 Compliant
- ISO 11607-1/2:2019 Compliant
- ASTM F88, F1886 and 1928 Compliant
- MS Word Format
- Digital Content - Instant Download