The SteriMega Plus autoclaves are steam sterilization units designed for processing a wide range of materials: solid or porous products and also liquids in pharmaceutical production.
The units offer high technical performance and GMP design in accordance with the applicable European standards: EN 285, PED, CE marking, etc.
The standard unit can be customized by addition of various technical features that provide enhanced performance to address almost any requirement.
Telstar has been developing sterilization systems for the pharmaceutical and medical devices industries as well as for R&D laboratories and animal facilities for over 30 years.
We have focused our experience in the field of sterilisation equipment under cGMP guidelines and we are now recognised as one of the market leaders and trendsetters in this segment worldwide.
Engineering and manufacturing practices follow ISO9001 procedures, ASME BPE criteria, GAMP guidelines etc. Design and construction meet the most stringent regulations and codes from Europe, USA and others concerning safety and pressure vessels.
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).
SteriMega Plus steam autoclaves offer you a high degree of cycle versatility: dry goods and porous loads are available as a standard.
The control system allows you to adjust vacuum/pressure rates, number of pulses, dwell time, etc.
Standard configuration also includes pre-programmed cycles such as Bowie & Dick test, Automatic chamber leak test and Automatic SIP vent filter.
The chamber, doors and process pipe work are constructed in stainless steel AISI 316L for a greater resistance to stress fatigue and corrosion.
Door seals are made by a means of a special silicone gasket which does not require permanent lubrication.
The chamber and door inner surfaces are mechanically polished to Ra ≤ 0.76 μm as standard, with the longitudinal edges rounded to facilitate cleaning. Option to Ra ≤ 0.51 is also available.
Piping joints are orbital or TIG welded. Removable connections are preferred, with in-line sanitary fittings sealed with pharmaceutical grade gaskets.
All pipe work connected to the chamber and chamber floor slopes towards the drainage and dead legs are minimised to avoid fluids stagnation.
An air differential seal separates the technical area from the cleanroom or contained laboratory.
The chamber internal surfaces are insulated and heated by means of separated black steam flowing through a full dimple jacket. The pure steam inlet is controlled by a PID valve and condensates are continuously evacuated off through the drainage, offering you excellent uniformity of temperatures (below 1ºC dispersion during all the sterilisation phase). This fulfils the requirements of EN-285.
The double access hinged panels at the front-side of the equipment are unique feature in that they provide unrestricted access for maintenance.
The compact technical area is designed to save space but keeping in mind ease of maintenance, allowing access to components and replacement of spares. Potential hot piping is insulated.
The OEM components such as valves, filters and measuring instruments are of the highest quality and state of the art technology. They are sourced from first brands widely available in the marketplace. Full material certificates, instrumentation calibration certificates are traceable to national standards and certificates of conformity are provided.
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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