Steridelta A autoclaves are steam and air mixture sterilization autoclaves specially designed for sterilizing large batches of parenteral solutions. The units have high technical performance, GMP design and comply with the applicable European standards: PED, CE marking, etc. They have a compact and modular structure allowing for quick installation and commissioning.
These units are fitted with an air recirculation system for mixing clean steam with air, which becomes the sterilization media. This process method should be recommended for complex plastic or glass containers such as pre-filled syringes or vials in which condensates may become stagnant, causing problems in the finished product. These autoclaves provide a superior drying finish thanks to the air recirculation system and thus, products are downloaded ready for packing and labelling.
Telstar globally represents one of the most advanced and quality alternatives in the field of sterilization 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).
When selecting an autoclave for terminal sterilization of liquids, the following information has to be taken into account:
Telstar SteriDelta autoclaves are especially designed for the terminal sterilization of liquids in closed containers. They are prepared to provide automatic differential pressure compensation based on the product probes temperature measurements, so deformation and damage of the plastic containers is prevented.
A cylindrical single-wall chamber with rectangular door/s made entirely from AISI 316 L stainless steel providing a high resistance to corrosion.
The doors are automated, typically of horizontal sliding motion.
Door seals are made by a means of a special silicone gasket which does not require permanent lubrication.
Chamber and door inner surfaces are polished to Ra ≤ 0,8 μm.
All components and pipe work parts such as valves, heat exchangers, pumps, filters, fittings, gaskets, etc. are supplied with quality certificates, according to current standards in sanitary installations and they are designed and installed for accessible maintenance and long life cycles. I.e. pneumatic-operated valves, Tri-Clamp type connections and process tubing are made of stainless steel AISI 316 L.
The double door chambers incorporate the necessary interlocks and each door has precaution mechanisms to ensure maximum operator safety.
The technical area is designed for ergonomic maintenance, with enough access to components and ease replacement of spares, almost without using tools. Potential hot piping is insulated.
The loading and unloading handling operations can be done either manually or, when large and heavy loads have to be handled, by using automatic mechanisms. The automatic loading/unloading system consists of a bench located in front of the door, where the pallets are placed. The pallets are then introduced by a mechanical system below the bench. Another alternative for big and heavy loads is to install the unit in a pit so that loading height is at floor level.
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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