ESR's pharmaceutical laboratory can provide:
- new onsite stability ovens
- large, secure storage capacity
- experienced, qualified staff
ESR can also undertake:
- the development of study protocols
- sample assessment using your specified methodology
Testing
It is a regulatory requirement that stability studies be undertaken for therapeutic products to certify and establish product expiry dates.
Stability testing is usually carried out on samples taken from three consecutive batches of each product, held at the appropriate temperatures in their sealed market packs.
- A dedicated stability testing oven or room is held at the proposed temperature and humidity at which the product is likely to be stored.
- A temperature/humidity recording device is used to assure temperature and relative humidity uniformity throughout the holding time (±2°C and ±5%RH).
- The data is kept as evidence of uniform storage conditions.
Special conditions
- Intermediate conditions (higher than that proposed for normal product storage) may be used to establish stability under conditions in other markets, or to confirm stability when the product may be exposed to more extreme conditions than expected for a short term.
- Initial accelerated stability studies may be carried out on samples held at even higher temperature and humidities.
- Data derived from these samples may be used to assign an expiry date of twice the time station at which the sample was found to be within stability limits.
- For example, if after 6 months at 40°C/75%RH, the sample still complies with expiry specifications then it is acceptable to assign a one-year expiry date to a product normally stored at 30°C. This is an accelerated means of assigning expiry dates when time is of the essence.
ESR's capabilities
Study Protocols
Protocols can either be developed in accordance with the appropriate regulatory requirements or followed to the customer's requirements.
Sample Assessment
- Products are assessed as required by the study protocol, covering physical, chemical and microbiological properties.
- Where appropriate, we are able to follow your specified methodology.
- When no methods/specifications are available, as in the development of new products, methods are developed and validated in accordance with ICH guidelines.
Sample Storage
- ESR uses dedicated storage facilities at our Kenepuru Science Centre in Porirua.
- These storage facilities are three walk-in rooms held at the ICH recommended conditions:
- 25oC/60%RH
- 30oC/65%RH
- 40oC/75%RH
- These rooms provide us with capacity for onsite storage for our clients.
Experience
- ESR has carried out stability studies for a variety of New Zealand and Australian clients.
- ESR pharmaceutical staff have experience in regulatory assessment and quality assurance, as well as experience with pharmaceutical companies overseas.