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 so we are nowadays one of the market leaders and trendsetters in this segment worldwide. Engineering and manufacturing practices follow ISO 9001 procedures, ASME BPE criteria, GAMP guidelines, etc. Design and construction meets the most stringent Regulations and Codes from Europe, USA and others concerning Safety and Pressure Vessels. To ensure the equipment meets your requirements, we work in partnership with you and a dedicated team follows your order as a unique project. We develop specific Quality Plans (DQ, IQ and OQ) and undertake factory acceptance testing (FAT). Multiple cycle possibilities: SteriMega Plus steam autoclaves offer you a high degree of cycle versatility: dry goods and porous loads are available as 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. Durable Construction: The chamber, doors and process pipe work are constructed in stainless steel AISI 316L for better resistance to stress fatigue and corrosion. Door seals by means of a special silicone gasket which does not require permanent lubrication. Option it is coupled with a compressed air back up system. Design for GMP: 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.