Wickham Laboratories is pleased to announce that the commissioning and validation (IQ, OQ, and PQ) has just been completed on our newest half-suit isolator for the sterility testing department. The addition of this isolator and a new BioQuell L3 gas generator will increase our testing capacity by nearly 30%.
Having a third isolator means that there will be two operating at all times making sterility testing operations more flexible and improving efficiency in maintenance and training activities. All three of our gas generators will also be validated against the three isolators at which point our sterility testing department will be equipped with a fully flexible system.
Given the steady rise in requests for sterility testing, we anticipate that this change will prove of value to clients via an increase in testing capacity and a reduction in the turnaround time required to process samples.
Sterility Testing at Wickham Laboratories
Any product injected or implanted into the body is required to be sterile. Sterility testing is therefore vital as there are many documented cases where a seemingly “sterile” product has been shown to contain organisms that are harmful or even life-threatening to the patient.
There are many different international standards that describe sterility testing e.g. USP, Ph. Eur, JP and ISO. The Pharmacopoeia state that sterility testing must be conducted under strict aseptic conditions by appropriately trained staff in a controlled environment akin to that used in sterile pharmaceutical manufacturing. Wickham Laboratories performs all sterility testing to these strict industry standard methods using half suit isolators in a Grade D environment. These isolators are regularly decontaminated using hydrogen peroxide vapour.
There are many benefits to sub-contracting with Wickham Laboratories for your sterility testing needs, including:
- Quick turnaround times
- Unrivalled sterility testing expertise (including cytotoxics)
- First rate testing facilities, equipment and personnel
- A named point of contact
- Quality testing supported by independent QA unit
- No resourcing issues or large CAPEX investments
For more information about our sterility testing capabilities, or to discuss your individual requirements, please feel free to contact us directly at +44 (0)1329 226600 or mail@wickhamlabs.co.uk.
