Sterility testing is a vital regulatory requirement for both pharmaceutical and medical device companies when bringing a product to market or assessing the post-launch safety of a product or device. Wickham Laboratories is equipped with a cleanroom suite which is ideal for sterility testing and we are pleased to regularly assist our clients with their projects in this area.
Our facilities operate a Grade D (ISO class 7, class 10,000) compliant cleanroom, which houses our four large capacity half-suit flexible film isolators (operating to Grade A for viable counts). Each isolator is equipped with the Millipore Steritest® sterility testing system, the method of choice for the pharmaceutical industry. Steritest® uses a totally enclosed filtration system giving a very high assurance of integrity of the test environment. This sterility test method minimises the risk of false positives from adventitious contamination as there are no open containers, membrane manipulations, or media transfers.
All of our isolators are sanitised using hydrogen peroxide vapour to further enhance the integrity of the test environment. This offers a level of test assurance that simply cannot be matched by the laminar flow cabinets used by some other laboratories.
Within the pharmaceutical industry, we have significant experience in dealing with sterile fluids e.g. irrigation, dialysis solutions, ointments, creams, vaccines, antibiotics, TPN solutions, controlled drugs and high potency or cytotoxic preparations. Our experienced team of sterility microbiologists are able to handle a wide range of presentations including vials, phials, ampoules, blow/fill/seal single dose containers, flexi packs, prefilled syringes, eye dropper packs, ointment tubes, jars and bottles. Contact us with your individual requirements.
For medical device sterility testing, we offer both membrane filtration and direct inoculation method depending on the nature of the test material and have experience handling a variety of devices such as dressings, catheters and tubing, medical plastics, contact and intraocular lenses, implant devices and more.
Find out more about some of the challenges and solutions involved in sterility testing by reading our editorial published in EPM Magazine (April, 2015).