Sterility testing isolator

type Afor the pharmaceutical industryfor production

Single-chamber isolator for sterility testing Chamber with 4 sleeves for work with sterile materials Possible to add airlock chamber and provide sterilization with with H2O2 Leak tightness class 3 according to ISO 10648-2 “A” class cleanliness according to EU GMP “Audit Trail” Compliant Option to decontaminate with H2O2 Electronic control system for automatic adjustment of basic operating modes managed by Siemens PLC Colour touchscreen control Jacket material: stainless steel AISI 304 Chamber material – AISI 316L with a thickness of 3.00 mm Polished surface finish, Ra < 0.6 µm Inlet filtration HEPA H14 - “A” Class cleanlinnes Easy-to-clean inner and outer surfaces Sliding trays in Airlock for easy material transfer (applicable with airlock) Oval holes with gloves for improved material handling Laminar flow 0,45 m/s ±20% Laminar Flow Laminar flow is used for “A” class cleanliness when unidirectional airflow must be ensured in a vertical orientation. A laminar frame is used to direct the flow— it is comprised of a special very finely perforated fabric. The velocity of laminar flow produced by the isolator technology amounts to 0,45 m/s ±20%. HEPA filters (H14), with an efficiency of 99.995% are used to filter incoming and outgoing air. This system is often coupled with air re-circulation inside the chamber. Positive Pressure The HVAC system allows for the formation of positive pressure in the interior of the isolator. This function is mostly used in case of a failure - compromised leak-proofness - and helps protect products.