The rapidly accelerating demand for combination products continues to drive technological advances in merging product types. However, the convergence of pharmaceuticals with medical devices brings a host of new challenges in stability studies and storage.
At a high level the FDA defines combination products as “therapeutic and diagnostic products that combine drugs, devices, and/or biological products”. When a pharmaceutical product (drug or biologic) meets a medical device, a combined product is created. This broad definition includes products ranging from pre-filled drug delivery systems (syringes, insulin injector pen, metered dose inhaler) to drug coated implants. Combination products are fully defined in 21 CFR 3.2(e).
With FDA requirements for drug testing of combination products being rigorous there needs to be adequate validation of stability throughout the specified shelf life of a combination product.
Medical device stability storage at Q1 Scientific
Due to the integration of active pharmaceutical ingredients (API) and antimicrobial agents, more medical devices are being considered combination products than ever before.
While the stability of these ingredients is often known, it must be tested in conjunction with the device and undergo a complete stability study according to the ICH guidelines.
We make the following stability conditions available for medical device stability storage and can store your samples at temperatures ranging from –80°C to 60°C+:
- 25°C ± 2°C / 60% RH ± 5% RH
- 30°C ± 2°C / 65% RH ± 5% RH
- 40°C ± 2°C / 75% RH ± 5% RH
- 5°C ± 3°C
- –20°C ± 5°C
With the option to rent exclusive rooms and reach-in cabinets we offer custom controlled temperature and humidity storage for initial development work.
For in-use stability studies we can also change the orientation of your samples from upright or on-the-side to inverted depending on your requirements. See our recent webinar to find out more about in-use stability studies.
Visit our services page to find out more about our stability storage, thermal cycling and photostability services.
FDA registration and DUNS number
To store combination products, Q1 Scientific is both FDA and DUNS registered. An FDA Establishment Identification (FEI) number is a unique identifier issued by FDA to track inspections of the regulated establishment or facility. A DUNS number is a useful resource for the FDA in identifying and verifying certain business information.
Q1 Scientific’s registration numbers are:
- FDA Establishment Identifier (FEI): 3014125714
- DUNS (Dun and Bradstreet): 985524204