Tray Sealer Performance Qualification PQ Protocol | Medical Device

$119.00
$119.00
Unavailable
per item

Our Tray Sealer Performance Qualification (PQ) 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 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
SKU: PQ-TRAY

Tray Sealer Performance Qualification Protocol

Our Tray Sealer Performance Qualification (PQ) Protocol is used to qualify equipment and related operating parameters used for medical device sterile packaging. The Tray Sealer Performance Qualification (PQ) Protocol can be utilized for a wide variety of sterile packaging material, makes and models of sealing equipment and defined processes. 
The Tray Sealer Performance Qualification (PQ) Protocol specifies the manufacturing conditions, controls, testing, and required acceptance criteria. The protocol includes the following elements: 
  • The manufacturing conditions, including operating parameters, process limits, and raw material inputs.
  • The data to be collected and when and how it will be evaluated
  • Tests to be performed and detailed acceptance criteria
  • Sampling plan, number of samples and frequency of sampling for both variable and attribute data. The protocol includes a sample size justification section that notes the number of samples required to provide sufficient statistical confidence.
  • ​Provision for addressing deviations from expected conditions and handling of nonconforming data.
  • The qualification protocol includes prerequisite requirements in terms of equipment installation, personnel training and qualification, and verification of materials used in the qualification process and the review and approval of the qualification protocol by appropriate departments.

To learn more about our Tray Sealer Performance Qualification  (PQ) Protocol contact us at [email protected] 
​
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

Customer's also viewed

Tray Sealer Qualification Protocols Bundle OQ - PQ | Medical Device

$199.00

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
Shop

Tray Sealer Operational Qualification OQ Protocol | Medical Device

$119.00

Our Tray Sealer Operational Qualification (OQ) 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 Operational Qualification (OQ) 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
Shop

Product Stability Shelf-Life Procedure | ISO 13485 | FDA QSR Compliant

$149.00
The Shelf Life Procedure defines the required testing needed to support medical device shelf life claims. The Shelf Life Procedure provides instruction on product considerations, accelerated aging studies, and post accelerated aging product testing and reports. 
  • ASTM F 1980-16 Compliant
  • ISO 13485:2016 Compliant
  • FDA QSR Compliant
  • MS Word Format
  • Digital Content - Instant Download
Shop

Accelerated Aging Study

$149.00
The Accelerated Aging Study simulates the effects of aging, weathering and handling by subjecting sterile packaged product to conditions considered greater than or equivalent to what a product may be subjected to in its expected life. The protocol includes formulas for calculating accelerated aging times to support 1 Year, 3 Year and 5 Year shelf life claims. The protocol also includes the required testing at each aging increment. Real time aging of product is also made part of the overall process. 
  • FDA Compliant
  • MS Word Format​
  • Adaptable to Multiple Packaging Systems
  • ​​Digital Content - Instant Download
Shop
Copyright © 2010-2024
  •