Page 1 of 5 MasterControl Analytics - Revision History Report Viewing Records 1-89 on Page 1 #999 Save Save As Filter Manage Columns Sort Rows Chart Details Export Revert Printable View Row Title Revision InfoCard Number Vault Release 1 Antibiotic Potency Assay: Cylinder-Plate Method 6 STP0085 2 ASTM Hemolysis 15 STP0093 3 ASTM Method F1670 Synthetic Blood Penetration 9 STP0061 4 Bacterial Endotoxins Test 15 STP0046 5 6 7 8 9 Bacterial Endotoxins Test, Gel Clot Technique Bacterial Filtration Efficiency (BFE) at an Increased Bacterial Filtration Efficiency (BFE) at an Increased Bacterial Reverse Mutation Assay (Ames test), Liquids or Soluble Chemicals Bacterial Reverse Mutation Assay (Ames Test), Solid Materials 10 STP0038 10 STP0009 11 STP0009 11 STP0098 12 STP0097 10 BFE and Delta P Tests 15 STP0004 11 Bioburden 14 STP0036 12 Biological Indicator (BI) Sterility Test 16 STP0079 13 Carbohydrate Test 8 STP0088 14 15 Chromosome Aberration Assay for a Medical Device Chromosome Aberration Assay for a Pharmaceutical/Chemical 10 STP0101 9 STP0102 16 Cleaning 13 STP0083 17 Clostridium Challenge 2 STP0200 18 Conductivity Analysis 4 STP0147 19 Determination Of Inhalation And Exhalation Resistance For Air-Purifying 5 STP0145 15 May 2018 6:43 PM 07 Feb 2018 3:42 PM 10:02 AM 13 Jul 2018 04 Sep 2018 9:57 AM 10:12 AM 2:13 PM 21 Sep 2018 4:04 PM 2:24 PM 3:32 PM 10:32 AM Effective 15 May 2018 6:43 PM 07 Feb 2018 3:42 PM 10:02 AM 13 Jul 2018 04 Sep 2018 9:57 AM 10:12 AM 2:13 PM 21 Sep 2018 4:04 PM 2:24 PM 10:32 AM Expiration
Page 2 of 5 20 5 STP0143 21 3 STP0143 27 Feb 2018 3:40 PM 27 Feb 2018 3:40 PM 22 4 STP0143 23 Differential Scanning Calorimetry 8 STP0027 17 Dec 2018 3:37 PM 17 Dec 2018 24 Dioctyl Phthalate (DOP) Aerosol Test 6 STP0015 11 Jan 2018 10:58 AM 11 Jan 2018 10:58 AM 25 Dioctyl Phthalate (DOP) Aerosol Test 7 STP0015 26 Disinfection Evaluation 8 STP0129 9:55 AM 9:55 AM 27 Dry Microbial Penetration 5 STP0191 28 Dry Microbial Penetration 4 STP0191 26 Mar 2018 26 Mar 2018 29 D-Value Determination 10 STP0048 13 Sep 2018 13 Sep 2018 30 Ethylene Oxide (EO) Sterilization 7 STP0152 10:42 AM 10:42 AM 31 Ethylene Oxide Sterilization - Batch Release 9 STP0118 20 Mar 2018 11:49 AM 20 Mar 2018 11:49 AM 32 Ethylene Oxide Sterilization Process 4 STP0151 30 Nov 2018 4:53 PM 30 Nov 2018 4:53 PM 33 Event Related Shelf Life Studies 4 STP0172 34 Flammability Of Clothing Textiles 6 STP0073 1:35 PM 1:35 PM 35 Functionality Processing For Test Articles Intended For Health Care Facilities 4 STP0159 11:19 AM 11:19 AM 36 Growth Promotion 7 STP0175 19 Jan 2018 19 Jan 2018 37 Helmke Drum Particle Count Test 7 STP0008 12 Nov 2018 12 Nov 2018 38 Hemoglobin Assay Using Copper(II)-Phthalocyanine Complex 8 STP0183 11 May 2018 11 May 2018 39 In Vitro Skin Irritation Assay for Chemicals 1 STP0187 16 Feb 2018 2:15 PM 16 Feb 2018 2:15 PM 40 Infusion Equipment for Medical Use 2 STP0185 07 Jun 2018 07 Jun 2018 41 Latex Particle Challenge 6 STP0005 42 Mass Extraction Leak Test 2 STP0140
Page 3 of 5 29 Jan 2018 29 Jan 2018 43 MEM Elution 10 STP0032 44 MEM Elution 9 STP0032 19 Mar 2018 2:50 PM 19 Mar 2018 2:50 PM 45 Metals Analysis Via Inductively Coupled Plasma - Mass Spectrometry 3 STP0190 06 Dec 2018 4:36 PM 06 Dec 2018 4:36 PM 46 Method 2 of Radiation Sterilization 2 STP0195 12:21 PM 12:21 PM 47 Micro BCA Protein Assay 8 STP0087 48 Microbial Analysis Of Water By Membrane Filtration 11 STP0057 12 Feb 2018 12 Feb 2018 49 Microbial Characterization and Gram Stain 15 STP0105 50 Microbial Genetic 11 STP0173 51 Microbial VITEK 2 Compact 11 STP0133 52 Microbial VITEK 2 Compact 10 STP0133 53 of Nonsterile Products: Microbial Enumeration Tests 7 STP0169 54 of Nonsterile Products: Tests for Specified Microorganisms 9 STP0165 55 of Nonsterile Products: Tests for Specified Microorganisms 8 STP0165 56 Nonporous Packaging 6 STP0170 05 Jan 2018 4:26 PM 05 Jan 2018 4:26 PM 57 Package Burst and Creep Tests 12 STP0060 12 Sep 2018 6:22 PM 12 Sep 2018 6:22 PM 58 Packaging 12 STP0150 4:23 PM 4:23 PM 59 Partial Thromboplastin Time Test PTT 11 STP0094 30 Jul 2018 30 Jul 2018 60 Product Inoculation 7 STP0039 1:20 PM 1:20 PM 61 Product Sterility 22 STP0077 12:12 AM 12:12 AM 62 Protective Clothing Material Resistance to Puncture 6 STP0069 10 May 2018 10 May 2018 63 Prothrombin Time Test PT 7 STP0095 4:37 PM 4:37 PM 64 15 STP0046-SPA
Page 4 of 5 Prueba de Endotoxinas Bacterianas SPA- Procedure 65 Quantification of Extractable Residue by Gravimetric Analysis 4 STP0134 2:18 PM 2:18 PM 66 Resistance Determination Study 6 STP0161 1:22 PM 1:22 PM 67 Salt Test Method to Assess Filtration Performance of Breathing System Filters (BSF) 2 STP0177 14 Jun 2018 14 Jun 2018 68 Sanitization 12 STP0123 04 Apr 2018 2:31 PM 04 Apr 2018 2:31 PM 69 Seal Peel Test 10 STP0065 02 Jan 2018 02 Jan 2018 70 Sizing/Counting Particulate Matter 10 STP0011 27 Mar 2018 27 Mar 2018 71 Standard Test Method For Determining Lint And Other Particles Generated In The Dry State - Gelbo Flex 6 STP0144 05 Dec 2018 05 Dec 2018 72 Steam Sterilization 10 STP0086 3:55 PM 3:55 PM 73 Steam Sterilizers 25 STP0130 20 Dec 2018 11:05 AM 20 Dec 2018 11:05 AM 74 Sterility and MPN Method Suitability (B/F) 14 STP0078 10 Apr 2018 1:55 PM 10 Apr 2018 1:55 PM 75 Sterility and MPN Method Suitability (B/F) 15 STP0078 76 Sterility Test Using an Isolator 21 STP0081 05 Oct 2018 05 Oct 2018 77 Sterilization 13 STP0049 22 Jan 2018 22 Jan 2018 78 STERRAD Sterilization 6 STP0153 11:02 AM 11:02 AM 79 Temperature/Humidity Distribution Study 7 STP0064 1:47 PM 1:47 PM 80 Testing Disinfectant Agents for Antimicrobial Action on Hard Surfaces 3 STP0135 11:40 AM 11:40 AM 81 Total Organic Carbon, Wet Oxidation Method 15 STP0028 18 May 2018 18 May 2018 82 Ultraviolet/Visible Spectroscopy - HP 8453 4 STP0023 08 Nov 2018 1:55 AM 08 Nov 2018 1:55 AM 83 Ultraviolet/Visible Spectroscopy (Evolution 60) 3 STP0154 84 USP Water Analyses 7 STP0024 10:55 AM 10:55 AM 85 Viral Filtration Efficiency (VFE) at an Increased 12 STP0010
Page 5 of 5 86 Viral Penetration ASTM Method F1671 87 Visual Inspection 3 STP0179 88 89 Water Resistance: Impact Penetration Wet Bacterial Penetration Testing 16 STP0062 11 STP0072 1 STP0188 26 Jan 2018 17 May 2018 06 Jul 2018 26 Jan 2018 17 May 2018 06 Jul 2018 Report Generated by MasterControl at 04 Jan 2019 11:05 AM