Key Features and benefits •Positive pressure with alarm set points to avoid any product contamination. •Single pass turbulent flow (EU GMP grade A) to maintain sterile conditions inside the isolator. •The glass vision panels are ‘gull wing’ type which hinge upwards and outwards. In the open position the doors are held open with gas struts. •Inflatable seal technology on all doors assures very low leakage rate in compliance with the most stringent leakage criteria stated in ISO 14644-7. •High resistance to H2O2 without giving rise to excessive out gassing and thus minimising bio-decontamination cycle time. •Design suitable for bio- decontamination using a broad range of systems to fulfill user requirements: · Integrated VHP (vaporized hydrogen peroxide) generator · Stand-alone VHP (vaporized hydrogen peroxide) generator · Unique Telstar Integrated iHPTM system (ionized Hydrogen Peroxide) generator offering the most cost effective bio-decontamination solution. •PLC-based user-friendly automated control with automatic leak-test function (pressure hold test). Sterility Test Isolator •As standard the units includes: · Internal Temperature monitoring sensor. · Internal Humidity monitoring sensor. · Telstar Ø200mm ‘CTS’ transfer port is offered in the end wall for the removal of waste materials. •Oval shaped gloveports which are designed for sound ergonomic posture while maximising operator arm movement. •Gloves are a Three-part design which enables changing of a glove without compromising Isolator sterility. •Grade AISI 316L stainless steel, fully welded, crevice free with smooth internal surfaces guarantees complete cleanability. •Support frame manufactured from AISI 304L stainless steel. •Lighting fixtures within each chamber with external access for maintenance. www.telstar-lifesciences.com 01 403 1011 I Telstar reserves the right to improvements and specifications changes without notice. iHP is trade mark of Sixlog and is used under agreement United Kingdom Unit 4, Shaw Cross Business Park Dewsbury, West Yorkshire WF12 7RF (UK) T +44 (0) 1924 455 339 F +44 (0) 1924 452 294 China No. 30 Jin Wen Road, Zhu Qiao Airport Ind. Zone, Nanhui District 201323 Shanghai (China) T +86 21 58 093 731 F +86 21 58 092 857

Telstar Range of sterility test Isolators Five types of Sterility Test Isolators are available in the Telstar standard range. A comprehensive range protecting the most critical step in production process… Sterility testing of sterile pharmaceutical products is required by the Pharmacopoeias to determine acceptability of a production lot. It is an essential element of sterilization validation and it must be performed in a manner which avoids the risks of both false positive and false negative results. consistently achieved & validated using a BI challenge. False positive results are generally...

Telstar Range of sterility test Isolators Five types of Sterility Test Isolators are available in the Telstar standard range. A comprehensive range protecting the most critical step in production process… Sterility testing of sterile pharmaceutical products is required by the Pharmacopoeias to determine acceptability of a production lot. It is an essential element of sterilization validation and it must be performed in a manner which avoids the risks of both false positive and false negative results. consistently achieved & validated using a BI challenge. False positive results are generally...

Key Features and benefits •Positive pressure with alarm set points to avoid any product contamination. •Single pass turbulent flow (EU GMP grade A) to maintain sterile conditions inside the isolator. •The glass vision panels are ‘gull wing’ type which hinge upwards and outwards. In the open position the doors are held open with gas struts. •Inflatable seal technology on all doors assures very low leakage rate in compliance with the most stringent leakage criteria stated in ISO 14644-7. •High resistance to H2O2 without giving rise to excessive out gassing and thus minimising bio-decontamination...