sop for pathogen detection from drain point 1 OBJECTIVE To describe the procedure for operating the pathogen detection from drain point. 2 SCOPE This procedure is applicable to operate the pathogen detection from drain point. 3 RESPONSIBILITY Microbiologist. 4 ACCOUNTABILITY Head – Q. C 5 ABBREVIATIONS SOP : Standard Operating Procedure Q .A. … Read more
sop for Validation protocol of steam sterilizer autoclave TABLE OF CONTENTS Sr. No. Title Page No. 1 PROTOCOL APPROVAL SHEET…………………………..…………….. 2 OBJECTIVE………………………………………………………………….. 3 SCOPE…………………………………………………………………..…… 4 RESPONSIBILITY……………………………………………………..……. 5 EQUIPMENT DESCRIPTION……………………………………………… 6 REQUIREMENT…………………………………………………………….. 7 LOAD PATTERN FOR VALIDATION OF AUTICLAVE…………………. 8 VALIDATION METHODOLOGY FOR AUTOCLAVE………..……..…… 9 SET PARAMETER…………………………………………..…………..…. 10 REVALIDATION CRITERIA………………………………………………… 11 FREQUENCY OF VALIDATION…………………………………………… … Read more
sop for Inoculum Preparation 1.0 OBJECTIVE 1.1 To lay down a procedure for Culture Suspension (Inoculum) preparation to determine 10 to 100 cfu/ml by Serial Dilution Method. 2.0 SCOPE 2.2 This procedure is applicable to the procedure of Culture Suspension (Inoculum) preparation of 10-100 cfu/ml which is used for Media Growth Promotion Test and … Read more
Sop for Operation of Airborne Particle Counter 1.0 OBJECTIVE 1.1 To lay down a Procedure for Operation of Airborne Particle Counter in Quality Control Department. 2.0 SCOPE 2.1 This procedure is applicable for Operation of Automatic Particle Counter 3.0 RESPONSIBILITY 3.1 Microbiologist. 4.0 ACCOUNTABILITY QC Manager 5.0 PROCEDURE 5.1 Logging in: Switch ON … Read more
sop for sampling and testing of drain water 1.0 OBJECTIVE 1.1 The objective of this SOP is to define the procedure for sampling (before sanitization and after sanitization) and testing of drain water. 2.0 SCOPE 2.1 This SOP is applicable for sampling for sampling (before sanitization and after sanitization) and testing of drain … Read more
SOP FOR PERSONNEL QUALIFICATION PROTOCOL FOR ASEPTIC AREA SUPERDEDES PROTOCOL No. AREA NAME S. No. Title Page No. 1.0 Protocol Approval 2.0 Objective 3.0 Scope 4.0 Responsibility 5.0 Reason for Qualification 6.0 Requalification Criteria 7.0 Training details 8.0 … Read more
HOLD TIME STUDY PROTOCOL FOR STERILIZED MEDIA S. No Description 1.0 Protocol Approval 2.0 Objective 3.0 Purpose and Scope 4.0 Responsibility 5.0 Qualification Team 6.0 Training 7.0 Methodology 8.0 Acceptance Criteria 9.0 Qualification report 10.0 Approval of qualification report 11.0 Re-qualification 12.0 Discrepancy And Corrective Action Report 13.0 Abbreviation 1.0 PROTOCOL APPROVAL This … Read more
sop for endotoxin challenge test 1.0 OBJECTIVE : To lay down a procedure for Endotoxin Challenge Test. 2.0 SCOPE : This SOP is applicable for Endotoxin Challenge Test in Microbiology Lab. Of Quality Control Department 3.0 RESPONSIBILITY : 3.1 Officer / Executive – QC (Microbiology) 4.0 ACCOUNTABILITY : 4.1 Head – QC 5.0 DEFINITION … Read more
swab testing of various surfaces for bioburden determination 1.0 OBJECTIVE 1.1 The objective of this SOP is to define the procedure for collection and testing of swabs of various surfaces for Bioburden determination in Microbiology lab. 2.0 SCOPE 2.1 This SOP is applicable for person taking the samples of swabs routine monitoring of aseptic area … Read more
gowning procedure for microbiological testing area 1.0 OBJECTIVE 1.1 The objective of this SOP is to define the procedure for gowning as well as degowning of any sterile gown employed for aseptic areas. 2.0 SCOPE 2.1 This SOP is applicable for for gowning as well as degowning of any sterile gown employed for aseptic areas … Read more