20240808 THERMA QC SOP Table of Contents_SIGNED.pdf

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