OEL LIMITS: Products are classified according to hazards levels that correspond to these five OEL levels as shown in the chart below :

Transcription

1 Isolator Integrity Leak-Testing Four level classification system of hourly leak rate Class Hourly Leak Rate Rh h -1 Pressure Integrity Test Methods 1 < 5 * 10-4 High Oxygen method, Pressure change method or Parjo method 2 <2.5 * 10-3 Medium Oxygen method, Pressure change method or Parjo method 3 <10-2 Low Oxygen method, Pressure change method or Constant Pressure method 4 <10-1 Constant Pressure method OEL (OPERATOR EXPOSAL LIMITS) CATEGORIES: OEL LIMITS: Products are classified according to hazards levels that correspond to these five OEL levels as shown in the chart below : Categories OEL 1 OEL 2 OEL 3 OEL 4 OEL 5 Hazard Description Harmful, and / or low pharmacological activity Harmful, and / or moderate pharmacological activity Moderately toxic and / or high pharmacological activity Toxic and / or very high pharmacological activity Extremely Toxic and / or extremely high pharmacological activity

2 Agitated Nutsche filter pressure dryer(anfd) Isolator: Chamber Size: 1250 L 650/550 W 800 H mm Hinged type flange for ANFD docking. Granulation Isolator: Turbulent Air Flow Integrated with Weighing scale, Sifter, RMG, FBD, Co-mill and Blender. Filtration Isolator Integrated with notches filter and mother liquor Filtration and drying Isolator

3 Integrated with notch filter and VTD 4-Tray R & D Isolator Turbulent Air Flow Isolator for Aseptic Filling and Capping Machine: Positive Pressure with respect to atmosphere. Unidirectional (laminar) Air Flow Minipleat HEPA/ULPA filters ISO : class ISo 5 Temperature controller to maintain isolator ambient temperature. Bag in bag out filters replacing method Integrated with VHP (vaporised hydrogen peroxide) as per requirement. Sterility Testing Isolator Positive Pressure with respect to atmosphere. Unidirectional (laminar) Air Flow Minipleat HEPA/ULPA filters ISO : class ISo 5 Integrated CIP (clean in place) Bag in bag out filters replacing method Integrated with VHP (vaporised hydrogen peroxide) as per requirement

4 Lyophilizer Isolator Positive Pressure with respect to atmosphere. Unidirectional (laminar) Air Flow Minipleat HEPA/ULPA filters Integrated CIP (clean in place) Bag in bag out filters replacing method Integrated with VHP (vaporised hydrogen peroxide) as per requirement. Provision for lyo loading. Rapid Transfer Port (RTP) Rapid transfer port used as the contamination free transfer of product into and out of an isolator. RTP (Interlocked, rotate type) active Alpha port bolted to the chamber at suitable location and passive with Beta canister is movable. MOC : AISI 316L Beta Canister : AISI 316L / HDPE Wash Gun SS 316/ PTFE wash gun Reach every corner of chamber Flexible silicone/ SS braded hose pipe Validation: We provide following documentation Functional Design Specification (FDS) Design Qualification (DQ) Factory Acceptance Test (FAT) Installation Qualification (IQ) Operation Qualification (OQ) Calibration Certificates MOC Certificates Site Acceptance Test (SAT) Operation and Maintenance Manual (OMM) Documentation will cover the following Tests Finishing Check Dimensional Check Levelling Check

5 Drain ability Check Electrical Components Check Lighting Level Check Utilities Check Fan Control Check Leak Tightness Test Air Change Rate Test Area Classification Check Recovery Time Determination Test Glove Breach Test Noise Level Check HEPA Filter Integrity Check RTP Operation Test Oxygen Reduction Check Deviation Reports