# Standard Operating Procedures Table of Contents

| Document Number | Document Title | Effective Date | Revision |
| --- | --- | --- | --- |
| 0.001 | Quality Policy Statement | 17-Feb-2021 | 1 |
| 1.001 | Total Quality Management (TQM) | 10-Dec-2013 | 3 |
| 1.002 | Supplier/Vendor Quality Audit | 17-Feb-2021 | 1 |
| 1.002.1 | Supplier Quality Audit Questionnaire | 6-Jan-2006 | 0 |
| 1.002.2 | Supplier/Vendor Quality Summary Report | 6-Jan-2006 | 0 |
| 1.002.3 | Supplier/Vendor Quality Audit Request Form | 9-Jan-2006 | 0 |
| 1.003 | Administration of Document Changes | 17-Feb-2021 | 5 |
| 1.003.1 | Document Change Request Form (DCR) | 13-Dec-2013 | 1 |
| 1.004 | Guidelines for the Preparation of Documentation | 1-Sep-2020 | 3 |
| 1.005 | Numbering Official Documents | 15-Mar-1997 | 1 |
| 1.006 | Requesting Official Documentation and Binders | 12-May-1997 | 0 |
| 1.006.1 | Binder Numbering Assignment Sheet | 12-May-1997 | 0 |
| 1.006.2 | Binder Table of Contents | 12-May-1997 | 0 |
| 1.006.3 | Document Request Form | 12-May-1997 | 1 |
| 2.003 | Admin of Customer Control System Programming & Document Changes | 12-Jul-2011 | 0 |
| 2.003.1 | Control System Software Change Request Form | 12-Jul-2011 | 0 |
| 3.001 | Complaint Procedure | 25-Feb-2013 | 0 |
| 3.001.1 | Customer Feedback and Complaint Form | 25-Feb-2013 | 0 |
| 3.004 | Procurement, Materials | 11-Apr-2022 | 5 |
| 3.010 | Disaster Recovery Plan - Major Communications Interruption | 30-Apr-1997 | 1 |
| 3.011 | Guidelines for Preparation of Turnover Package | 15-Jul-1993 | 2 |
| 3.011.1 | Turn Over Package (TOP) Table of Contents | 24-Jan-2000 | 4 |
| 3.011.2 | Turnover Package Documentation Requirements | 24-Jan-2000 | 1 |
| 5.001 | Receiving & Storage | 28-Mar-2014 | 5 |
| 5.002 | Fabrication Drawings, Pharmaceutical | 28-Mar-2014 | 9 |
| 5.002.1 | Fabrication Drawing Title Block - Hi Purity/Pharmaceutical | 26-Dec-2013 | 0 |
| 5.003 | Fabrication Drawings for Semiconductor | 4-Dec-1995 | 3 |
| 5.003.1 | Fabrication Drawing Title Block - Non-Validated | 22-Apr-1999 | 3 |
| 5.004 | Materials Preparation for GTAW in Pharmaceutical | 6-Mar-2012 | 7 |
| 5.005 | Gas Tungsten Arc Welding (GTAW) | 8-Aug-2018 | 10 |
| 5.005.1 | Coupon Weld Log | 24-Mar-2014 | 8 |
| 5.005.2 | Welding Procedure Specification (WPS) | 15-Jul-1993 | 5 |
| 5.005.3 | Procedure Qualification Records (PQR) | 8-Apr-1999 | 1 |
| 5.005.4 | Welder Performance Qualifications (WPQ) | 15-Mar-2012 | 2 |
| 5.005.5 | GTAW Weld Log | 8-Aug-2018 | 6 |
| 5.005.6 | AWS D1.1 Structural Welder Certification | 7-Nov-2011 | 1 |
| 5.005.7 | Welding Operator Performance Qualifications(WOPQ) | 15-Mar-2012 | 0 |
| 5.005.8 | Weld Log | 7-Dec-2018 | 2 |
| 5.007 | Purging Set-Up | 6-Mar-2012 | 5 |
| 5.013 | Brazing Procedure | 7-Jan-2019 | 6 |
| 5.013.1 | Brazing Procedure Specification (BPS) | 5-Jul-1993 | 2 |
| 5.013.2 | Brazing Procedure Qualification Records (PQR) | 5-Jul-1993 | 2 |
| 5.013.3 | Brazer/ Brazing Operator Performance Qualifications (BPQ) | 5-Jul-1993 | 2 |
| 5.013.4 | Thera Braze Joint Log | 7-Dec-2018 | 0 |
| 5.014 | Brazer Material | 12-May-1997 | 0 |
| 5.016 | Orbital Equipment Box | 21-Apr-1997 | 0 |
| 5.016.1 | Orbital Equipment Request | 21-Apr-1997 | 0 |
| 5.024 | Weld Program | 6-Mar-2012 | 5 |
| 5.024.1 | Weld Program/Schedule Development Worksheet (Model 207) | 15-Jul-1995 | 0 |
| 5.024.2 | Weld Program/Schedule Development Worksheet (Model 107) | 15-Jul-1995 | 0 |
| 5.025 | Ductwork Cleaning - Level 1 | 20-Jan-2017 | 7 |
| 5.025.1 | Computer Input Room Generated Log | 20-Jan-1995 | 5 |
| 5.025.2 | Duct Cleaning Log | 20-Jan-1995 | 6 |
| 5.028 | Bonding Procedure for PVDF Socket Bench Fusion Method | 11-Jun-1997 | 0 |
| 5.029 | Bonding Procedure for PVDF Socket Hand Fusion Method | 12-Aug-1997 | 0 |
| 5.030 | Bonding Procedure for PVDF Bead and Crevice Free Fusion Method | 11-Jun-1997 | 0 |
| 5.031 | Bonding Procedure for PVDF Infrared 63 Fusion Method | 15-Jul-1997 | 0 |
| 5.032 | Bonding Procedure for PVDF Infrared 225 Fusion Method | 25-Jul-1997 | 0 |
| 5.034 | Coaxial Plastic Tubing Installation | 18-Sep-2000 | 2 |
| 5.035 | Bending Procedure for Rigid PVC | 7-Jul-2000 | 1 |
| 5.036 | PFA Flaretek Tube Fitting Assembly | 6-Mar-2012 | 1 |
| 5.037 | Ductwork Cleaning - Level 3 | 20-Jan-2017 | 3 |
| 5.038 | Ductwork Cleaning - Level 2 | 29-Nov-2021 | 5 |
| 5.039 | HEPA Removal and Installation | 18-Oct-2019 | 1 |
| 5.040 | For PVC and CPVC Bonding Procedure | 4-Oct-2000 | 0 |
| 5.041 | For PVC and CPVC Bonder Performance Qualification | 25-Nov-2014 | 4 |
| 5.041.1 | Bonder Performance Qualification | 25-Nov-2014 | 1 |
| 5.043 | Bonder Procedure for PP Infrared 63 Fusion Method | 11-Oct-2000 | 0 |
| 5.044 | Carbon Steel Pipe Fabrication | 12-Mar-2012 | 2 |
| 5.046 | Gas Tungsten Arc Welding (GTAW) - AL-6XN Alloy | 5-Jan-2012 | 1 |
| 5.047 | Carbon Steel Bending | 12-Aug-2003 | 0 |
| 5.047.1 | Carbon Steel Bending Coupon | 12-Aug-2003 | 0 |
| 5.048 | Medical Gas Final Tie-In | 1-Sep-2009 | 1 |
| 5.049 | Pipe Bending - MIL-STD-1627 | 23-Jan-2004 | 1 |
| 5.049.1 | Appendix - Pipe Bending - MIL-STD-1627 | 5-Feb-2004 | 1 |
| 5.050 | Grinding/Polishing/Blending for Stainless Steel Surfaces | 27-Jan-2005 | 1 |
| 5.051 | Bonding Procedure PP and PVDF Infrared Fusion | 28-Sep-2011 | 1 |
| 5.052 | Post-Weld Heat Treatment | 7-Jan-2019 | 0 |
| 5.053 | Guidelines for Laser Marking | 9-Dec-2014 | 0 |
| 5.054 | Passivation of Welded Stainless Steel Surfaces | 20-Sep-2017 | 0 |
| 5.054.1 | Passivation Report for Welded Stainless Steel Surfaces | 20-Sep-2017 | 0 |
| 5.056 | Cleaning Tubing for Process Gas Systems | 23-Oct-2020 | 0 |
| 5.058 | Press Fitting Installation | 11-Apr-2022 | 0 |
| 6.001 | Calibration Program | 23-Feb-2004 | 0 |
| 6.004 | Leak Testing - Hydrostatic | 2-Oct-2023 | 3 |
| 6.004.1 | Pressure Test Form | 25-Jul-2024 | 5 |
| 6.005 | Leak Testing - Pneumatic | 2-Oct-2023 | 1 |
| 6.006 | Cleaning and Flushing | 6-Nov-2013 | 1 |
| 6.006.1 | Cleaning and Flushing Log | 27-Jan-2005 | 0 |
| 6.007 | Leak Testing - Helium | 2-Oct-2023 | 4 |
| 6.008 | Digital Inclinometer Calibration | 6-Mar-2012 | 1 |
| 6.008.1 | Calibration Sheet for Digital Inclinometers | 19-Jul-2011 | 1 |
| 6.009 | Leak Testing - Process Piping | 2-Oct-2023 | 3 |
| 6.010 | Leak Testing - Piping with Press-Joints | 2-Oct-2023 | 0 |
| 6.016 | Calibration Procedure for Temperature Transmitters | 21-Jul-2003 | 0 |
| 6.016.1 | Temperature Transmitter Calibration Sheet | 21-Jul-2003 | 0 |
| 6.017 | Calibration Procedure for Pressure Transmitters | 21-Jul-2003 | 0 |
| 6.017.1 | Pressure Transmitter Calibration Sheet | 21-Jul-2003 | 0 |
| 6.018 | Calibration Procedure for Chart Recorder | 4-Aug-2003 | 0 |
| 6.018.1 | Relative Humidity & Temperature Chart Recorder Calibration Sheet | 4-Aug-2003 | 0 |
| 6.019 | Calibration Procedure for Wall Thermostat | 4-Aug-2003 | 0 |
| 6.020 | Calibration Procedure for Resistance Temperature Detector | 4-Aug-2003 | 0 |
| 6.020.1 | Resistance Temperature Detector (RTD) Calibration Form | 4-Aug-2003 | 0 |
| 6.021 | Calibration Procedure for Analog Type Pressure Gauge | 5-Jan-2005 | 0 |
| 6.021.1 | Therma Caliber Sheet for Pressure Gauge | 5-Jan-2005 | 0 |
| 6.022 | General Chemical Sanitization Procedure for DI Distribution Loops | 3-Mar-2005 | 0 |
| 6.022.1 | Chemical Sanitization of DI Distribution Loops | 3-Mar-2005 | 0 |
| 6.023 | DI Water Quality Check for DI Skid in Thera's Facility | 8-Dec-2005 | 0 |
| 6.023.1 | DI Water Quality Check | 8-Dec-2005 | 0 |
| 6.024 | Start-Up/Ops Procedure for Shop Clean Steam Generator | 4-Sep-2012 | 0 |
| 6.024.1 | Clean Steam Generator Safety, Start-Up, Testing and Shutdown Form | 4-Sep-2012 | 0 |
| 6.025 | Pressure Test, Closed Coax Containment | 28-Apr-2015 | 1 |
| 6.026 | Cycle Purging | 8-Aug-2018 | 0 |
| 6.026.1 | Cycle Purge Test Log | 8-Aug-2018 | 0 |
| 6.027 | Cleaning Welded Piping Fabrication | 25-Jul-2024 | 0 |
| 7.002 | Quality Control Examination of Pharmaceutical Material | 28-Mar-2014 | 9 |
| 7.002.1 | Material Examination Log | 7-Dec-2018 | 7 |
| 7.002.2 | Specification Acceptance Criteria | 20-May-1995 | 4 |
| 7.002.4 | Rejected Items Log | 7-Jul-1999 | 0 |
| 7.002.5 | Valve Examination Report | 14-Jun-2012 | 1 |
| 7.002.6 | Pump Examination Report | 26-Sep-2012 | 0 |
| 7.002.7 | Heat Exchanger Examination Report | 26-Sep-2012 | 0 |
| 7.002.8 | Instrument Examination Report | 26-Sep-2012 | 0 |
| 7.002.9 | Pressure Vessel Examination Report | 26-Sep-2012 | 0 |
| 7.002.10 | Equipment Examination Report | 3-Oct-2013 | 0 |
| 7.003 | Quality Control Examination for Semiconductor Material | 6-Mar-2012 | 3 |
| 7.004 | Purge Gas Certification | 6-Mar-2012 | 5 |
| 7.004.1 | Purge Gas Certification Log | 5-Feb-2014 | 5 |
| 7.005 | Automatic GTAW Weld Examination | 6-Mar-2012 | 8 |
| 7.006 | Borescoping | 8-Mar-2012 | 7 |
| 7.008 | Brazing Performance Qualification | 6-Mar-2012 | 2 |
| 7.009 | Automatic GTAW Welder Qualification | 6-Mar-2012 | 5 |
| 7.010 | Manual Welding Qualification | 6-Mar-2012 | 2 |
| 7.010.1 | Welder/Brazer Status Record | 22-Apr-1999 | 0 |
| 7.024 | Coupons | 6-Mar-2012 | 9 |
| 7.025 | PVDF Bonder Qualification | 11-Jun-1997 | 0 |
| 7.026 | PVDF Coupons | 11-Jun-1997 | 0 |
| 7.026.1 | PVDF Coupon Log | 11-Jun-1997 | 0 |
| 7.027 | Analytical Testing | 1-Aug-1997 | 0 |
| 7.027.1 | Analytical Test Report | 1-Aug-1997 | 1 |
| 7.028 | PP Coupons | 11-Oct-2000 | 0 |
| 7.029 | PP Bonder Qualification | 11-Oct-2000 | 0 |
| 7.031 | Cleanroom Gowning and Material Handling | 3-Jun-2003 | 0 |
| 7.032 | UHP Cleanroom Gowning and Material Handling | 3-Jun-2003 | 0 |
| 7.033 | Operation, Calibration & Maintenance for Alloy Analyzer | 6-Mar-2012 | 1 |
| 7.033.1 | Alloy Material Inspection Report | 11-Jul-2011 | 1 |
| 7.034 | Pipe Slope Verification | 15-Feb-2007 | 0 |
| 8.001 | Preventive Maintenance Review and Implementation | 10-Jun-1997 | 0 |
| 8.001.1 | Equipment Maintenance Log | 10-Jun-1997 | 2 |
| 8.001.2 | Preventive Maintenance HVAC Checklist | 10-Jun-1997 | 2 |
| 8.001.6 | Preventive Maintenance Checklist | 10-Jun-1997 | 1 |
| 8.002 | Start-Up Operator Training Outline | 7-Mar-2005 | 0 |
| 8.002.1 | Equipment Start-Up Operator Training Outline | 7-Mar-2005 | 0 |
| 8.002.2 | Equipment Start-Up Training Log | 7-Mar-2005 | 0 |
| 8.004 | Fan Testing | 3-Mar-1997 | 1 |
| 8.004.1 | Fan Test Report | 3-Mar-1997 | 2 |
| 8.005 | Air Outlet Testing | 3-Mar-1997 | 1 |
| 8.005.1 | Air Outlet Test Report | 3-Mar-1997 | 2 |
| 8.006 | VAV Air Outlet Testing | 3-Mar-1997 | 1 |
| 8.006.1 | VAV Air Outlet Test Report | 3-Mar-1997 | 2 |
| 8.007 | Operational Procedure for Pitot Tube Traverse | 3-Mar-1997 | 1 |
| 8.007.1 | Duct Traverse Test Report | 3-Mar-1997 | 2 |
| 8.008 | Operational Procedure for Duct Leakage Test | 31-Mar-2015 | 3 |
| 8.008.1 | Air Duct Leakage Test Summary | 3-Mar-1997 | 1 |
| 8.009 | Laboratory Fume Hood | 7-Mar-1997 | 2 |
| 8.009.1 | Laboratory Fume Hood Test Report | 7-Mar-1997 | 3 |
| 8.010 | Gas Cylinder Cabinet | 7-Mar-1997 | 2 |
| 8.010.1 | Gas Cylinder Cabinet Certification Report | 7-Mar-1997 | 3 |
| 8.010.2 | Gas Cylinder Cabinet Certification Report - Silane Cabinets Only | 7-Mar-1997 | 2 |
| 8.011 | Pump Testing | 7-Mar-1997 | 1 |
| 8.011.1 | Pump Test Report | 7-Mar-1997 | 2 |
| 8.012 | Flow Measuring Station | 3-Mar-1997 | 1 |
| 8.012.1 | Flow Measuring Station Report | 3-Mar-1997 | 2 |
| 8.013 | Apparatus Coil Testing | 3-Mar-1997 | 1 |
| 8.013.1 | Apparatus Coil Test Report | 3-Mar-1997 | 2 |
| 8.014 | Procedure for HEPA Filter Challenge | 15-Sep-2020 | 2 |
| 8.014.1 | HEPA Filter Locations | 7-Mar-1997 | 2 |
| 8.015 | Operational Procedure for Room Pressurization | 14-Oct-2020 | 2 |
| 8.018 | Guidelines for Preparing of Final Certified TAB Reports | 10-Jun-1997 | 0 |
| 8.021 | Sound Testing | 21-Apr-1997 | 0 |
| 8.021.1 | Noise Criterion (NC) Levels | 21-Apr-1997 | 2 |
| 8.024 | Biohazard Class II Cabinet Electrical Tests | 5-Mar-1999 | 1 |
| 8.026 | Room Air Change Rate | 7-Mar-1997 | 1 |
| 8.026.1 | Air Changes Per Hour Test Report | 7-Mar-1997 | 2 |
| 8.028 | Start-Up & Verification Procedures for Air Handlers | 14-Jun-1999 | 0 |
| 8.028.1 | Start-Up Sheet Air Handling Unit | 14-Jun-1999 | 0 |
| 8.028.2 | Supplementary Form 1 | 14-Jun-1999 | 0 |
| 8.028.3 | Supplementary Form 2 | 14-Jun-1999 | 0 |
| 8.029 | Start-Up Procedure & Verification for Variable Frequency Drives | 14-Jun-1999 | 0 |
| 8.029.1 | Start-Up Sheet Variable Frequency Drives | 14-Jun-1999 | 0 |
| 8.030 | Start-Up Procedure & Verification of Packaged Air Conditioning Units | 14-Jun-1999 | 1 |
| 8.030.1 | Start-Up Sheet Packaged Air Conditioning Unit | 14-Jun-1999 | 1 |
| 8.031 | Start-Up Procedure & Verification of Condensing Unit | 14-Jun-1999 | 0 |
| 8.031.1 | Start-Up Sheet Condensing Unit | 14-Jun-1999 | 0 |
| 8.032 | Start-Up Procedure & Verification for Fans | 14-Jun-1999 | 0 |
| 8.032.1 | Start-Up Sheet Fan | 14-Jun-1999 | 0 |
| 8.033 | Start-Up Procedure & Verification for Pumps | 14-Jun-1999 | 0 |
| 8.033.1 | Start-Up Sheet Pump | 14-Jun-1999 | 1 |
| 8.034 | Start-Up Procedures & Verification for Filter Housing | 14-Jun-1999 | 0 |
| 8.034.1 | Start-Up Sheet Filter Housing | 14-Jun-1999 | 0 |
| 8.035 | Start-Up Procedures & Verification for Heat Exchangers | 14-Jun-1999 | 0 |
| 8.035.1 | Start-Up Sheet Heat Exchanger | 14-Jun-1999 | 0 |
| 8.036 | Start-Up Procedure & Verification for Boilers | 14-Jun-1999 | 0 |
| 8.036.1 | Start-Up Sheet Boiler | 14-Jun-1999 | 0 |
| 8.037 | Start-Up Procedures & Verification for Coils | 14-Jun-1999 | 0 |
| 8.037.1 | Start-Up Sheet Coils | 14-Jun-1999 | 0 |
| 8.038 | Start-Up Procedures & Verification for Air Compressors | 14-Jun-1999 | 0 |
| 8.038.1 | Start-Up Sheet Air Compressor | 14-Jun-1999 | 0 |
| 8.039 | Start-Up Procedures & Verification for Chillers | 14-Jun-1999 | 0 |
| 8.039.1 | Start-Up Sheet Chiller | 14-Jun-1999 | 0 |
| 8.040 | Start-Up Procedures & Verification for Vacuum Pumps | 14-Jun-1999 | 0 |
| 8.040.1 | Start-Up Sheet Vacuum Pump | 14-Jun-1999 | 0 |
| 8.041 | Start-Up Procedures & Verification for Furnace/Duct/Unit Heaters | 14-Jun-1999 | 0 |
| 8.041.1 | Start-Up Sheet Furnace/Duct/Unit Heater | 14-Jun-1999 | 0 |
| 8.042 | Start-Up Procedures & Verification for VAV & CV Terminal Boxes | 14-Jun-1999 | 0 |
| 8.042.1 | Start-Up Sheet VAV & CV Terminal Boxes | 14-Jun-1999 | 0 |
| 8.043 | Start-Up Procedure & Verification for Humidifiers | 14-Jun-1999 | 0 |
| 8.043.1 | Start-Up Sheet Electric Humidifier | 14-Jun-1999 | 0 |
| 8.044 | Start-Up Procedures & Verification for Tanks | 14-Jun-1999 | 0 |
| 8.044.1 | Start-Up Sheet Tank | 14-Jun-1999 | 0 |
| 8.045 | Start-Up Procedures & Verification for Cooling Towers | 14-Jun-1999 | 0 |
| 8.045.1 | Start-Up Sheet Cooling Tower | 14-Jun-1999 | 0 |
| 8.046 | Start-Up Procedures & Verification for Hydronic Piping | 14-Jun-1999 | 0 |
| 8.046.1 | Start-Up Sheet Hydronic Piping | 14-Jun-1999 | 0 |
| 8.047 | Biohazard Class II Cabinet Downflow Velocity Test | 5-Mar-1999 | 1 |
| 8.048 | Biohazard Class II Cabinet Inflow Velocity | 5-Mar-1999 | 1 |
| 8.049 | Biohazard Class II Cabinet Airflow Smoke Patterns | 5-Mar-1999 | 1 |
| 8.050 | Biohazard Class II Cabinet HEPA Filter Leak Test | 5-Mar-1999 | 1 |
| 8.051 | Biohazard Class II Cabinet Lighting Intensity Test | 5-Mar-1999 | 1 |
| 8.052 | Biohazard Class II Cabinet Noise Level Test | 5-Mar-1999 | 1 |
| 8.053 | Biohazard Class II Cabinet Vibration Test | 5-Mar-1999 | 1 |
| 8.054 | Microbiological Decontamination Procedure | 5-Mar-1999 | 1 |
| 8.055 | Biohazard Class II Cabinet HEPA Filter Changeout | 5-Mar-1999 | 1 |
| 8.056 | Biohazard Class II Cabinet Leak Test | 5-Mar-1999 | 1 |
| 8.057 | Biohazard Safety Cabinet Test Report Summary Sheet | 5-Mar-1999 | 1 |
| 8.057.1 | Biohazard Safety Cabinet Test Report Summary Sheet | 5-Mar-1999 | 1 |
| 8.057.2 | Biohazard Safety Cabinet Test Report Details I | 5-Mar-1999 | 1 |
| 8.057.3 | Biohazard Safety Cabinet Test Report Details II | 5-Mar-1999 | 1 |
| 8.057.4 | Biohazard Safety Cabinet Test Report Details III | 5-Mar-1999 | 0 |
| 8.058 | Biohazard Class II Cabinet Site Installation Assessment Tests | 1-Oct-2003 | 0 |
| 8.059 | HEPA Filter Leak Test (Oil-Based Challenge) | 1-Oct-2003 | 0 |
| 8.059.1 | HEPA/ULPA Filter Leak Scan | 1-Oct-2003 | 0 |
| 8.060 | HEPA Filter Leak Test (Oil-Based Challenge) Aerosol Total Penetration Method | 23-Dec-2003 | 0 |
| 8.061 | Start-Up Procedure & Verification of Smoke Fire Damper | 1-Mar-2005 | 0 |
| 8.061.1 | Start-Up Sheet Smoke Fire Damper | 1-Mar-2005 | 0 |
| 8.062 | Operational Procedure for Particle Count - ISO 14644-1 | 25-Jan-2021 | 2 |
| 8.063 | Replacement of Motor Control Center Starters | 14-Jun-2019 | 0 |