We are working for a future where manufacturers know exactly what the patient will receive.
Better devices for patients, faster and with more confidence. Efficient, sustainable supply chains. Long-term properties known without waiting several years.
A2P2™
Product-lifetime evidence, built from the material—not an assumption.
A2P2 is the patented enterprise framework and live platform for mechanism-driven accelerated ageing. It gives R&D, quality and regulatory teams a faster, traceable route from material behaviour to a defensible lifetime decision.
EXPERIENCE A2P2 DISCUSS ENTERPRISE LICENSING
337 → 71 DAYS
Bioreactor stability programme
£40 MILLION
Avoided waste associated with an adhesive shelf-life extension
8 YEARS
Prediction compared with continuous field service
A live platform for lifetime decisions
A2P2 brings experimental evidence, material-specific calculations, study design and decision records into one governed environment. The protected platform supports mechanism-specific workflows across creep, hydrolysis, oxidation, spectroscopy, thermal analysis and device-level Q₁₀ analysis.
Bioprocess bag
Life in the Environment
A2P2-Intelligence
From material behaviour to a defensible decision.
STANDARDS AND REGULATORY PATHWAY
Standards alignment
A2P2 within the medical device standards landscape, from proposal to published standard.
ISO
In progress
ISO/TC 150/WG 7 New
Shelf life and stability of surgical implants
UK expert · Preliminary work item
In progress
ISO/TC 194/WG 1
Biological evaluation across the device life cycle
UK expert
Published
ISO 11607-1 / -2
Sterile barrier shelf-life evidence
ISO 10993-1
Lifecycle context for degradation risk
ISO 13485
Traceable, mechanism-justified records
ISO 14971
Mechanism maps for risk files
ASTM
Proposed
ASTM F04
New guide on accelerated ageing of medical devices from Arrhenius principles
Proposer · Confirmed for F04
In progress
ASTM WK100588
New guide on experimental determination of Q₁₀ temperature coefficients
Technical Contact
Published
ASTM F1980-21
Accelerated ageing of sterile barrier systems and medical devices
Led the revision work for two years
FDA
In progress
FDA MDDT
A2P2 submitted to the Medical Device Development Tools programme
Under review
A2P2 is not a mandated method. Dr Nazli Gulsine Ozdemir holds these roles in an individual capacity. They do not represent ASTM, BSI, FDA or ISO, and do not imply endorsement of A2P2.
INTELLECTUAL PROPERTY
Patents
Granted, allowed and pending patents across the UK, Europe and the US.
UK
Pending
GB2518440.9
UK divisional
Pending
Pending
GB2518802.0
UK divisional
Pending
Pending
GB2605212.6
UK application
Pending
Allowed
GB2518812.9
UK divisional, GB2644619
Allowed for grant
Granted
GB2639843
UK patent
Granted 1 April 2026
EP
Under examination
EP25159512.0
European application, EP4621674 A1
Under examination
US
Pending
US 19/074,590
US application, US 2026/0268341 A1
Pending
1 · Define the system
Materials, interfaces, processing, sterilisation and the intended lifetime claim.
2 · Identify the governing behaviour
Select the mechanism and experimental pathway that describe the product actually manufactured.
3 · Calculate and verify
Determine the acceleration factor, study duration, temperature domain and verification plan.
4 · Create the decision record
Connect source data, calculations, acceptance criteria and limitations for review.
Designed for enterprise adoption
A2P2 is not a one-off test. An implementation combines an annual framework and platform licence, a foundational programme around the organisation’s lead system, method transfer, laboratory implementation, team training and defined scientific governance.
Standards and regulatory pathway
A2P2 is being developed alongside active standards and regulatory work—not presented as an already mandated method. Dr Nazli Gulsine Ozdemir led the ASTM F1980 revision work for two years, is Technical Contact for ASTM WK100588 on experimental Q₁₀ determination, and has proposed a new ASTM F04 guide on accelerated ageing from Arrhenius principles. She is a UK expert within ISO/TC 194/WG 1 and ISO/TC 150/WG 7, contributing to new work on the shelf life and stability of surgical implants. A2P2 has been submitted to the FDA Medical Device Development Tools programme.
The result is an internal capability that can evolve with the evidence and the standards landscape.
EXPLORE THE PUBLIC DEMONSTRATION START A LICENSING DISCUSSION
FOR TESTING LABORATORIES
Become an A2P2 Certified Lab.
Offer your clients accelerated ageing done the right way.
Mechanism first
Material-specific ageing, not one default for every material.
E&L-ready samples
Aged samples that represent the end of shelf life.
Licence and training
A2P2 platform access and training for your team.
A2P2 Certified Lab is a Gulsine Ltd programme, delivered under the Authorised Service-Provider Licence and separate from ISO/IEC 17025 accreditation.
Some of our partners
