Hot dry air depyrogenation sterilization is generally used for materials that tolerate high temperatures such as metal or glass. It is the method of choice whenever possible for depyrogenation as the glass surface, being in direct contact with the product, can be the origin of pyrogenic contamination and dry air is an effective agent for destroying pyrogens. It also has the advantage that the processed material emerges dry at the end of the cycle.
Telstar globally represents one of the most advanced and quality alternatives in the field of sterilisation equipment under cGMP guidelines.
Engineering and manufacturing practices follow ISO 9001 procedures, USP and EU pharmacopoeias, GAMP guidelines, etc. Our aim is to make your validation faster, easier and efficient for you.
To ensure Telstar equipment meets your requirements we work in partnership with you and a dedicated team follow your order as a unique project. We develop specific Quality Plan (DQ, IQ and OQ) and undertake factory acceptance testing (FAT).
All parts submitted to high temperatures are made of AISI 316L stainless steel, with an external cladding in AISI 304. Thermal insulation with rock wool achieves better yields and energy savings.
Standard models feature chamber dimensions designed to provide easy handling of the load and maximum air filtration area. The loading cart has to be sized for being transported by one person and the load should be fully processed under ISO-5 air flow.
Telstar uses high quality OEM components which are widely available in the market, allowing us to react quickly and efficiently when replacements and essential maintenance are required.
A set of 99,99% efficiency HEPA filters (H13, DOP at 0,3µm) are installed on one side of the chamber.
Telstar ovens are designed to attain temperature uniformity better than ± 15°C rated at 250°C with the empty chamber. These results ensure obtaining temperature distributions in a repetitive way throughout the whole chamber, as quoted in the United States Pharmacopoeia (USP) statements.
A differential pressure transducer controls the chamber overpressure in relation to the surrounding room. A separate one will control the chamber filter pressure drop and provides an automatic warning in case the HEPA filters become blocked.
There is a side port for Pt100 probes for validation purposes.
The unit is supplied with our complete SCADA control system PharmaSter ®. This system includes an industrial PC with touch-screen colour display. The software allows not only for supervision and control of the process, but also compiling, storing and processing the whole information in a batch oriented mode. The system is fulfilling 21 CFR Part 11 guidelines.
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