Master Procedure List · MAN0004 9 Chemical Hygiene Plan and Safety Manual MAN0005 5 Biosafety Manual MAN0006 16 Policy and Procedures Manual MAN0007 14 Validation Master Plan MAN0008

Master Procedure List

Page | 1 Report Printed: 14 Nov 2019

This document is for informational purposes only and can change at any time.

Procedure Number

Revision Title

MAN0001 16 Nelson Laboratories Quality Manual

MAN0002 11 Custodial Manual

MAN0003 5 Statistical Control Manual

MAN0004 9 Chemical Hygiene Plan and Safety Manual

MAN0005 5 Biosafety Manual

MAN0006 16 Policy and Procedures Manual

MAN0007 14 Validation Master Plan

MAN0008 1 BSL-3 Manual

MAN0009 1 Microsoft Dynamics® Customer Relationship Management (CRM) System

SOP0001 24 Management of Controlled Procedures and Forms

SOP0006 26 Customer Specific Testing Instructions

SOP0007 14 Significant Figures, Rounding, and Data Calculation

SOP0008 7 Instruction Signs, Labels and Other Posted Materials

SOP0019 11 Temperature and Environmental Measurement and Control

SOP0020 28 In-House Environmental Monitoring

SOP0022 29 Media Preparation and Labeling

SOP0023 10 Creation of Master Reagent Recipes (MRR) & Preparation of Reagents

SOP0024 7 Waste Disposal

SOP0025 18 Glassware Processing, Handling, and Storage

SOP0027 24 Water System

SOP0028 13 Glassware Monitoring

SOP0029 5 Emergency Circumstances

SOP0030 11 Pest Control Procedure

SOP0032 17 Biological Indicator Shipments

SOP0033 6 Emergency Power Generator

SOP0034 6 Respiratory Protection and Respirator Use

SOP0035 10 Contracts & Confidentiality

SOP0036 10 Visitor Check-In

SOP0038 10 Daily Verification




SOP0039 12 Change Management

SOP0041 26 Sterility Media Production

SOP0043 5 Failure Mode Effects Analysis (FMEA)

SOP0044 10 Facilities Security

SOP0046 8 IT Compliance Policies and Procedures

SOP0047 11 Computer Systems Access Security Policy

SOP0048 8 Computer Systems: User Responsibilities

SOP0051 5 Computer Systems: Management and Maintenance

SOP0059 12 Microbiological Culture Maintenance and Preparation

SOP0062 11 Hood and HEPA Filter Certification

SOP0063 6 Flowmeter Calibration

SOP0064 4 Timer Calibration

SOP0065 10 General Temperature and Thermometer Calibration

SOP0067 14 General Calibration and Maintenance

SOP0068 9 Non-Routine Repairs

SOP0069 7 Equipment Receiving

SOP0070 9 Pressure and Vacuum Gauge Calibration

SOP0071 5 Sponsor, Vendor, and Off-Site Equipment

SOP0072 7 Micropipette Verification

SOP0073 10 Controlled Chamber Verification

SOP0074 7 Lockout/Tagout of Equipment

SOP0076 15 Requisition and Purchasing Process

SOP0077 26 Incoming Receiving and Inspection of Supplies

SOP0079 29 Log In

SOP0080 11 Identification, Handling and Disposition of Test Samples

SOP0081 20 Data Recording and Correction

SOP0082 17 Quality Records and Archives

SOP0083 7 Hosting Regulatory Inspectors

SOP0084 8 Signature and Initial File

SOP0085 26 Final Reports

SOP0087 5 Attire, Personal Hygiene and Health Standards




SOP0089 6 Management Responsibilities

SOP0090 13 Study Director Responsibilities

SOP0092 16 GLP Study Procedures

SOP0093 7 Customer Feedback Handling

SOP0094 6 Responsibilities, Deputies, and Organizational Structure

SOP0095 12 Review and Auditing of Logbooks and Binders

SOP0096 15 Corrective and Preventive Action

SOP0098 17 Training System

SOP0099 21 Quality Committee and Management Review Procedures

SOP0101 6 Final Report Retraction

SOP0102 14 DQ, IQ, OQ, and PQ of EFS and Software

SOP0103 22 Internal Audits

SOP0104 6 Test Sample Subcontracting

SOP0106 25 Supplier Management

SOP0107 12 External Audits

SOP0109 5 Handling of DEA Form 222

SOP0110 4 Power-of-Attorney for Handling of DEA Form 222

SOP0112 13 Chain of Custody for Controlled Substances

SOP0115 13 Test Method Validation

SOP0116 9 Expression of Uncertainty

SOP0117 8 Proficiency and Competency Testing Program

SOP0118 11 Spreadsheet Control

SOP0119 10 Control Charts and Duplicate Analyses

SOP0120 23 Product Sterility Cleanrooms

SOP0121 26 Cleanroom Environmental Monitoring for Microorganisms

SOP0122 15 Product Sterility Gowning Qualification

SOP0123 19 Sterility Media Growth Promotion

SOP0124 15 Isolator Cleaning and Maintenance

SOP0125 17 Isolator Environmental Monitoring

SOP0127 6 Isolator Safety Procedures

SOP0128 6 Sterilization/Instrument Wrap Procedures




SOP0130 4 Computer Systems: Validation and Change Control

SOP0131 12 Backup/Restore Procedures

SOP0132 11 Sample and Equipment Shipping

SOP0133 9 MasterControl Document Owner Guidelines

SOP0134 12 Structure of Controlled Procedures

SOP0136 13 Quality Events, Investigations, Retests, and Study Discontinuations

SOP0137 18 Sample Discrepancy

SOP0138 1 Company Vehicle Drivers Policy

SOP0140 22 Document Imaging

SOP0142 1 Assets Recycling and Disposal

SOP0143 4 Assets Register

SOP0144 3 Pricing Policies and Procedures

SOP0145 13 Complaint Handling

SOP0147 13 UNIFlow Process Configuration and Validation

SOP0149 2 Customer Portal

SOP0150 11 BI Sterility Cleanroom Procedures

SOP0152 8 Product Sterility Failure Investigations

SOP0153 27 Product Sterility Cleanroom Cleaning Procedures

SOP0154 11 Quality Assurance Unit Responsibilities

SOP0155 16 Media Quality Control Testing

SOP0156 5 Ethylene Oxide Safety Guidelines

SOP0157 6 Rees Environmental Monitoring System

SOP0158 15 Instrument Processing

SOP0159 4 On-Site Supplier/Subcontractor Audit Process

SOP0162 10 Media QC Culture Preparation

SOP0163 8 SQL Report Development and Validation

SOP0164 9 Nonconforming Supplies and Services

SOP0166 12 Product Sterility Instrument and Supply Processing

SOP0167 14 Quality Assessment of Incoming Supplies

SOP0169 4 Quality Overview

SOP0170 1 Standard Work




SOP0171 5 Data Integrity

SOP0172 5 Spreadsheet Validation

SOP0173 3 New Reprocessed Item Adoption Evaluation

SOP0174 9 Specialty Glassware Processing

SOP0176 2 Software Development Validation Methodology

SOP0177 1 Colony Counting

SOP0178 1 Healthcare/Specialized Reprocessing: General Operation and Culture Maintenance/Preparation

SOP0180 5 Process Challenge Device Preparation

SOP0181 4 Sampling Plan for Inspection of Process Challenge Devices and Components

SOP0182 4 MasterControl System Administration

SOP0183 2 Non-Sponsor Tours and Job Shadowing

SOP0184 2 Software Configuration/Code and Validation

SOP0186 2 Marketing Overview

SOP0187 3 Inhibition Overview

SOP0188 1 Bioequivalence Study Procedure

SOP0190 1 Technical Consulting Procedure

SOP0191 3 Log In for Embedded Lab

SOP0192 2 Inter-Facility Transfer

SOP0193 2 Form Reconciliation

SOP0195 1 IT Compliance Audits

SOP0197 2 Glassware Processing, Handling, and Storage

SOP0461 1 Clinical Sample Handling

STP0004 17 BFE and Delta P Tests

STP0005 7 Latex Particle Challenge

STP0007 15 Viral Filtration Efficiency (VFE) Test

STP0008 8 Helmke Drum Particle Count Test

STP0009 12 Bacterial Filtration Efficiency (BFE) at an Increased Challenge Level

STP0010 13 Viral Filtration Efficiency (VFE) at an Increased Challenge Level

STP0011 11 Sizing/Counting Particulate Matter

STP0012 9 Synthetic Blood Penetration Resistance

STP0014 9 Sodium Chloride (NaCl) Aerosol Test




STP0015 7 Dioctyl Phthalate (DOP) Aerosol Test

STP0016 13 Sterilant Gas Residue Analysis

STP0017 8 USP Physicochemical Tests For Plastics

STP0018 4 USP Oxidizable Substances

STP0020 3 Water Residuals in Solids

STP0021 6 Infrared Spectroscopy

STP0023 5 Ultraviolet/Visible Spectroscopy - HP 8453

STP0024 7 USP Water Analyses

STP0026 3 Hydrogen Peroxide Determination

STP0027 8 Differential Scanning Calorimetry

STP0028 15 Total Organic Carbon, Wet Oxidation Method

STP0029 11 pH Determination

STP0030 6 Alcohol Determination

STP0031 9 Agar Overlay

STP0032 10 MEM Elution

STP0034 11 Environmental Monitoring: Incubation and Enumeration of Samplers

STP0035 12 Standard Plate Count and Membrane Filtration

STP0036 15 Bioburden

STP0038 10 Bacterial Endotoxins Test, Gel Clot Technique

STP0039 8 Product Inoculation

STP0040 6 Coliform Counts - Membrane Filtration

STP0044 5 Radiation Dose Audit

STP0045 15 Biological Indicator Population Verification

STP0046 15 Bacterial Endotoxins Test

STP0048 10 D-Value Determination

STP0049 14 Sterilization

STP0050 5 Method 1 Validation of Radiation Sterilization

STP0051 5 Substantiation of a Selected Sterilization Dose: Method VDmax

STP0052 17 Bioburden Resistance Monitoring and Control of Media

STP0057 11 Microbial Analysis Of Water By Membrane Filtration

STP0058 16 Aerosol Challenge Procedure




STP0060 12 Package Burst and Creep Tests

STP0061 9 ASTM Method F1670 Synthetic Blood Penetration

STP0062 17 Viral Penetration ASTM Method F1671

STP0063 9 Physical Testing of Medical Gloves

STP0064 8 Temperature/Humidity Distribution Study

STP0065 10 Seal Peel Test

STP0066 9 General Tensile Testing of Fabric, Plastic, and Other Materials

STP0067 11 Tear Resistance of Plastics and Fabrics

STP0069 6 Protective Clothing Material Resistance to Puncture

STP0070 4 Residual Powder on Gloves

STP0071 10 Water Resistance: Hydrostatic Pressure

STP0072 12 Water Resistance: Impact Penetration

STP0073 6 Flammability Of Clothing Textiles

STP0074 6 Surface Tension Determination

STP0075 6 Bubble Emission Leak Test

STP0076 8 Dye Migration

STP0077 22 Product Sterility

STP0078 15 Sterility and MPN Method Suitability (B/F)

STP0079 17 Biological Indicator (BI) Sterility Test

STP0081 21 Sterility Test Using an Isolator

STP0082 10 Isolator Package Validation

STP0083 13 Cleaning Validation

STP0084 2 Dissolved Oxygen

STP0085 6 Antibiotic Potency Assay: Cylinder-Plate Method

STP0086 11 Steam Sterilization Validation

STP0087 8 Micro BCA Protein Assay

STP0088 8 Carbohydrate Test

STP0090 11 Aging Study

STP0091 10 Decontamination of Isolators

STP0092 12 Complement Activation

STP0093 15 ASTM Hemolysis




STP0094 11 Partial Thromboplastin Time Test – PTT

STP0095 7 Prothrombin Time Test – PT

STP0097 13 Bacterial Reverse Mutation Assay (Ames Test), Solid Materials

STP0098 12 Bacterial Reverse Mutation Assay (Ames test), Liquids or Soluble Chemicals

STP0099 8 USP Purified Water And EP Purified Water In Bulk

STP0100 2 Sodium Hypochlorite Determination

STP0101 11 Chromosome Aberration Assay for a Medical Device

STP0102 10 Chromosome Aberration Assay for a Pharmaceutical/Chemical

STP0103 4 Microbial Retention

STP0104 2 ISO 18562 Particulates Testing and VOC Sampling

STP0105 16 Microbial Characterization and Gram Stain

STP0106 6 Qualitative and Quantitative Growth Promotion of Agar Media for Sponsors

STP0107 9 Ethylene Oxide Exposure - BIER Vessels and STERIS EO Sterilizers

STP0112 15 Aerosol Spore Challenge (Exposure Chamber Method) ASTM F1608

STP0114 5 Biological Indicator Incubation Reduction Validation

STP0115 1 Tissue Log Reduction

STP0117 2 Modified Microbial Limits Test For Human Tissue

STP0118 10 Ethylene Oxide Sterilization - Batch Release

STP0123 12 Sanitization

STP0124 2 Antimicrobial Susceptibility Test: Zone of Inhibition

STP0126 2 USP Sodium Chloride Assay for Heparin Lock Flush Solution

STP0127 2 USP Sodium Chloride Assay

STP0128 4 Water Content by Karl-Fischer Titration

STP0129 9 Disinfection Evaluation Validation

STP0130 26 Steam Sterilizers

STP0131 5 USP Antimicrobial Preservative Effectiveness Test

STP0132 5 USP, EP Antimicrobial Preservative Effectiveness Test

STP0133 12 Microbial VITEK 2 Compact Identification

STP0134 4 Quantification of Extractable Residue by Gravimetric Analysis

STP0135 3 Testing Disinfectant Agents for Antimicrobial Action on Hard Surfaces

STP0136 1 Minimum Inhibitory Concentration -MIC /Minimum Bactericidal Concentration -MBC




STP0137 3 Stand-Alone Disinfection Efficacy Test For Contact Lens Care Products

STP0140 2 Mass Extraction Leak Test

STP0141 2 Regimen Disinfection Efficacy Test For Contact Lens Care Products

STP0142 9 Survival / Kill Time Verification

STP0143 5 Determination Of Valve Leakage For Air-Purifying Respirators

STP0144 7 Standard Test Method For Determining Lint And Other Particles Generated In The Dry State - Gelbo Flex

STP0145 5 Determination Of Inhalation And Exhalation Resistance For Air-Purifying Respirators

STP0147 4 Conductivity Analysis

STP0149 7 Dye Immersion

STP0150 12 Packaging Validation

STP0151 4 Ethylene Oxide Sterilization Process Validation

STP0152 8 Ethylene Oxide (EO) Sterilization Validation

STP0153 6 STERRAD Sterilization Validation

STP0154 3 Ultraviolet/Visible Spectroscopy (Evolution 60)

STP0156 2 Evaluation of Antimicrobial Finishes

STP0158 3 Time Kill Study

STP0159 5 Repeat Process For Test Articles

STP0161 6 Resistance Determination Study

STP0163 3 Spectrophotometric Assay For Low Level Hydrogen Peroxide

STP0164 2 Container Closure Integrity Test: Bacterial Immersion

STP0165 9 Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms

STP0169 7 Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests

STP0170 6 Nonporous Packaging Validation

STP0172 4 Event Related Shelf Life Studies

STP0173 12 Microbial Genetic Identification

STP0174 4 ISO 16604 Viral Penetration

STP0175 7 Growth Promotion

STP0177 4 Salt Test Method to Assess Filtration Performance of Breathing System Filters (BSF)

STP0178 1 Cleaning Validations for Newly Manufactured Medical Devices and Single Use Implants

STP0179 4 Visual Inspection

STP0180 4 Modified ASTM F2638 Test Method




STP0181 2 Chemical Characterization of Materials

STP0182 1 Diffusive Flow Integrity Test Value

STP0183 8 Hemoglobin Assay Using Copper(II)-Phthalocyanine Complex

STP0184 1 Bubble Point Ratio Integrity Test Value (ITV) Validation

STP0185 2 Infusion Equipment for Medical Use

STP0186 1 Tissue Cleaning Validations

STP0187 2 In Vitro Skin Irritation Assay for Chemicals

STP0188 2 Wet Bacterial Penetration Testing

STP0189 2 Endoscope Monitoring

STP0190 3 Metals Analysis Via Inductively Coupled Plasma - Mass Spectrometry

STP0191 5 Dry Microbial Penetration

STP0192 3 Hydraulic Method for Determining Burst Properties – ISO 13938

STP0193 1 Gurley Test Methods

STP0194 1 Thermal Disinfection Using Biological Methods and A0 Methods

STP0195 2 Method 2 Validation of Radiation Sterilization

STP0196 1 Liquid Chemical Sterilization Validation

STP0197 1 Single Use Reprocessing

STP0198 3 Whole Glove Viral Barrier Testing

STP0199 1 Filter Integrity Test

STP0200 2 Clostridium Challenge

STP0201 1 Sterilant Gas Residue Analysis Using Headspace

STP0203 1 Total Hydrocarbon Content by Gas Chromatography

STP0204 1 Glutaraldehyde Analysis By UV/VIS Spectroscopy

STP0205 1 Abrasion Resistance Using the Sutherland Rub Tester

STP0206 1 Shipping and Distribution Tests

STP0207 2 MTT Assay: Quantitative Evaluation of Cytotoxicity

STP0208 1 In Vitro Skin Irritation Assay for Medical Devices

WI0008 7 Operating the TOC Analyzer

WI0021 4 Hydra Datalogger Electronic Record Storage

WI0032 6 Forklift Operations

WI0034 3 Test Codes and Price Schedule Production




WI0035 4 Hose Connects to Deionized Water Ports

WI0050 6 N-Store Process

WI0055 7 Standard Plate Count and Membrane Filtration Tips and Examples

WI0060 6 Shipping Supplies for Sample Collection

WI0087 10 Operating the Instron

WI0095 7 Copyright Guidelines

WI0101 18 Log In Typing Work Instruction

WI0103 5 Environmental Chamber Safety Instructions

WI0105 7 Melting Agar Media in the Microwave

WI0108 9 Management of Document Collaboration and Approval

WI0109 6 Remote Operation Through PC of a PMS Particle Counter

WI0111 8 Management of Logbooks and Binders in MasterControl

WI0113 11 Management of External References

WI0117 5 Steam Kettle Cleaning Procedures

WI0119 8 Bioburden Plate Counting Procedure

WI0120 4 Biological Indicator (BI) Carrier Work Instruction

WI0121 5 Liquid Particle Counter Cleaning

WI0123 14 Using MasterControl in Professional Development

WI0125 21 Final Report Format Guidelines

WI0126 9 Formation and Maintenance of Final Report Templates

WI0128 13 Processing Final Reports

WI0129 14 Processing Amended Reports

WI0130 11 Processing Draft Reports

WI0133 8 Quality Control Testing of Media for USP 61 and 62 Use

WI0134 6 Processing In-House BI Population Verification Reports

WI0136 11 Media Stability Testing

WI0138 5 UNIFlow Data Entry for Media

WI0142 8 Handling of Inconclusive Product Sterility Results

WI0143 3 Swabbing Technique for Extraction

WI0144 4 Mycobacterium terrae Preparation

WI0148 1 Measuring Pressure Differential and HEPA Velocity




WI0150 3 Respirator Fit Test Procedure

WI0151 1 Thermal Sanitization

WI0152 2 Gas Chromatography Maintenance

WI0154 6 Sulfuric Acid/NoChromix Cleaning Procedure

WI0155 8 Cleanroom Scrub Sink Monitoring

WI0157 1 Operating the Solvent Evaporator

WI0158 6 Processing Automated Reports

WI0160 6 BET Naturally Occurring Endotoxin (NOE) Preparation and Maintenance

WI0161 8 Operating the Ethylene Oxide (EO) Sterilizers

WI0162 6 3500 XL Genetic Analyzer Calibration and Maintenance

WI0164 5 Creating a New Media Recipe

WI0165 4 Preparation of Sterility Test Articles Prior to Irradiation

WI0166 1 Replacement of Sterilizer Ink Cartridge and Re-inking the Time/Date Stamp

WI0167 4 Accumet XL250 pH Meter Operation

WI0168 3 Ultraviolet/Visible Spectrometer HP 8453 Yearly Verification

WI0169 1 UNIFlow Data Correction

WI0170 5 Shipping of Radiation Samples

WI0172 3 UNIFlow Logbook Management

WI0173 7 Measuring PCD Supplies

WI0174 4 Absorbance Reader Calibration

WI0176 7 BFE and VFE Challenge Preparation Intellectual Property

WI0177 2 Quality Event Revision Process

WI0178 3 Processing of Irradiated Samples

WI0179 5 Radiation Sample Handling

WI0180 9 Entering New Contacts Into Databases

WI0181 3 Qualification of Packaging Microbial Aerosol Nebulizers

WI0182 3 Sample Handling for Subcontracted Chemistry Analysis

WI0183 4 Bacteriostasis Testing for Sterilization Validation

WI0185 2 Solvent Evaluation

WI0187 2 Healthcare Reprocessing Culture Maintenance

WI0189 2 Healthcare Reprocessing Transfer Process




WI0190 4 Maintenance and Calibration Administration Instructions

WI0191 6 Operating the F2638 Instrument

WI0192 4 Repeater Pump Operation

WI0195 1 Front Desk BSL Work Instruction

WI0197 2 Clorox Handling

WI0198 6 Healthcare Reprocessing Analyst Test Preparation

WI0199 2 Temperature Profiling for Healthcare Sterilization Validations

WI0200 8 Media Out of Specification Quarantine

WI0201 1 Project Estimate Templates

WI0203 9 Final Report and Mail Delivery

WI0205 4 Cell Culture

WI0206 1 Failure Investigation Process

WI0207 5 Genetic Data Interpretation

WI0208 3 Custom Library Additions

WI0210 8 Document Revision Approval and Periodic Review

WI0211 6 Quality Records / Archive Administration Instructions for Document Control

WI0212 2 Operation of Washer Disinfectors

WI0213 2 Job Descriptions

WI0214 1 Quotes and Orders (CRM)

WI0215 2 Invoices

WI0216 5 External References

WI0219 6 Product Sterility Gowning

WI0220 6 Product Sterility Flow Manager Procedure

WI0221 5 Loading Patterns for Media Sterilization

WI0222 5 Product Sterility Test Session Environmental Monitoring

WI0223 3 Product Sterility Active Air Sampling

WI0224 7 Product Sterility Test Session Sanitization

WI0228 5 Product Sterility Processing Items Into the Cleanroom

WI0234 2 Redwood IV Sterilizer Operation

WI0236 5 Inhibitory Substance Screening of Detergents, Disinfectants and Potentially Inhibitory Sponsor Materials

WI0238 10 Scanning and Verifying




WI0239 6 Operating the UV/Vis Spectrophotometer for Dye Immersion Analysis

WI0240 8 Cleaning of Bioburden Non-Work Surfaces

WI0241 1 Dilution Blank Preparation

WI0242 2 Treatment Evaluations

WI0246 4 Weekly In-House Water System Sampling

WI0248 4 Sample Return Coordination

WI0249 3 Bioburden Inoculum Creation

WI0251 3 PCD Label Template

WI0252 2 Ames Cultures: Growth, Freezing, and Phenotype Verification

WI0253 1 Microscopic Particulate Characterization and Imaging

WI0256 2 Isolator Ammonia Leak Test

WI0257 4 Isolator Cleaning and Maintenance Requirements

WI0258 2 Isolator Glove and Sleeve Change

WI0259 2 Isolator Bio-Decontamination Unit Regeneration

WI0260 3 Isolator Bio-Decontamination Unit Reservoir Fill

WI0261 2 Isolator Test Session Environmental Monitoring

WI0262 2 Isolator Particulate Monitoring

WI0263 4 Isolator Test Session Environmental Monitoring Excursion Response

WI0264 2 Batch Controller Operation

WI0265 1 NDA Processing Guide

WI0266 1 Watson-Marlow Dispensing Pump

WI0267 6 Void & Discontinuation Work Instruction

WI0268 1 Crucible Cleaning Work Instruction

WI0269 4 Media Screening

WI0270 4 Kill Process Overview

WI0271 8 Customer Specific Testing Instruction Creation

WI0272 3 Plate Pouring

WI0273 8 Customer Specific Testing Instruction Administration

WI0274 2 CQS: Axio AZ10 Imager Z2, Metafer

WI0275 2 Culture and Challenge Preparation

WI0278 1 Quality Agreement Processing Guide




WI0279 1 Handling of Unacceptable Media Lots

WI0297 1 Compatibility Spike Preparation

WI0298 2 PhiX174 Stock Preparation Intellectual Property

WI0300 1 Return to Log-In/New Root Number Process

WI0306 2 BET CSE Rehydration

WI0307 2 Utility Water Testing

WI0308 1 BI Population Verification: Manufacturer’s Test Method

WI0309 1 Probe Verification for Qualifications

WI0310 1 Ultraviolet/Visible Spectrometer HP 8453 Verification

WI0311 2 Cleaning and Reprocessing of Particulate Glassware

WI0313 2 CRM Study Tracking

WI0314 1 CRM Batch Dates

WI0315 2 LPC Operation

WI0318 1 Order Knowledge

WI0319 1 Tracking Emails and Phone Calls in CRM

WI0320 2 Automated Gram Stainer Cleaning and Maintenance

WI0321 4 Lid Processing

WI0322 2 Miele Automatic Glassware Washers

WI0324 1 Mass Extraction

WI0325 1 VITEK 2 Compact Maintenance

WI0326 1 Use of DataTrace Probes

WI0327 1 Vibration Table

WI0328 2 Drop Tester and Shock Tests

WI0329 2 Mechanical Shaker

WI0330 1 Compression Tester

WI0331 1 Environmental Chambers

WI0332 2 Altitude Tester

WI0333 1 Concentrated Impact

WI0334 1 Steris Automatic Glassware Washer

WI0336 1 CQS: MasterControl

WI0337 1 CQS: WinKQCL Software, ELx808 Absorbance Microplate Readers




WI0338 1 CQS: SphereFlash Automatic Colony Counter

WI0339 1 CQS: ATC Mass Extractor ME2, LeakRx

WI0340 1 CQS: Agilent UV/Vis Spectrophotometers for Dye Immersion, ChemStation

WI0341 1 CQS: T.M. Electronics Burst Tester, Winwedge

WI0342 1 CQS: Reytek Particle Counter for F2638

WI0343 1 CQS: Instron using Bluehill 3 software

WI0344 1 CQS: DocuWare

WI0349 1 CQS: Differential Scanning Calorimetry (DSC) STARe System and Software

WI0350 1 CQS: ICP-MS Using MassHunter Software

WI0355 1 Preparation of Solutions and Standard Curve Dilutions containing an Internal Standard

Documents

Master Procedure List · MAN0004 9 Chemical Hygiene Plan and Safety Manual MAN0005 5 Biosafety Manual MAN0006 16 Policy and Procedures Manual MAN0007 14 Validation Master Plan MAN0008