Accelerated Aging Study

SKU: AASP

$119.00

Unavailable

per item

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

Quantity

Add to Cart

Accelerated Aging Study

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.

For more information about our accelerated aging study protocol contact us at info@aplyon.com

Customer's also viewed

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

$99.00

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

Bar Sealer Qualification Protocols Bundle OQ - PQ | Medical Device

$199.00

Bar Sealer Operational Qualification (OQ) and Performance Qualification (PQ) Protocol Bundle product includes a Bar Sealer OQ and a PQ Protocol. Each 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 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 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

4 Sided Seal (4SS) Qualification Protocols Bundle OQ - PQ | Medical Device

$199.00

4 Sided Sealer Sealer Operational Qualification (OQ) and Performance Qualification (PQ) Protocol Bundle product includes a 4 Sided Sealer OQ and a PQ Protocol. Each protocol is a comprehensive 22 page document developed specifically to address regulatory requirements for qualifying medical device sealing equipment/process used to seal sterile packaging. The 4 Sided 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