PERFORMANCE QUALIFICATION FOR TABLET COMPRESSION

PERFORMANCE QUALIFICATION FOR TABLET COMPRESSION TABLE OF CONTENTS 1.0 Approval 2.0 Objective 3.0 Responsibility 4.0 System Description 4.1 Equipment Identification 4.2 Description of Operation 4.3 Standard Operating Procedure Established During Operation Qualification 5.0 Validation Plan and Methodology 6.0 Performance Qualification Procedure 6.1 Effect of Machine Speed 6.2 Effect of Powder Level in Hopper 6.3 Effect … Read more

Factory Acceptance Test for Tablet Compression

Factory Acceptance Test for Tablet Compression machine name : FALCON B4 TYPE 35 STN “B” TOOLING TAB, MACHINE Client Name & address : FALCON, AHMEDABAD, INDIA document name : factory acceptance test PROTOCOL no. : Revision no. : 00 MACHINE SR. NO. : Table of Contents  1.… SYSTEM DESCRIPTION :………………………………………………………………………………………………….. 2.… SYSTEM CHECKES :…………………………………………………………………………………………………………. 2.1 … Read more

Site Acceptance Test Protocol for Tablet Compression

Site Acceptance Test Protocol for Tablet Compression machine name : FALCON B4 TYPE 35 STN “B” TOOLING TAB, MACHINE Client Name & address : FALCON, AHMEDABAD, INDIA document name : SITE acceptance test PROTOCOL PROTOCOL no. : Revision no. : 00 MACHINE SR. NO. : Table of contents Sr. No. Title Page No. 1.0         Approval … Read more

USER REQUIREMENT SPECIFICATIONS OF COMPRESSION MACHINE

USER REQUIREMENT SPECIFICATIONS OF COMPRESSION MACHINE Sr. No. Table of Contents 1 General 2 Salient Features 3 Operational Requirements 4 Utilities 5 Maintenance 6 Commissioning and Documentation 7 Training 8 Packaging 9 Deviations 10 Delivery  TECHNICAL SPECIFICATION  S. No. Parameters Required Specifications 1.0 General Equipment No.     Description Use FIeld Identification Sound Reduction: The … Read more

INSTALLATION QUALIFICATIONS OF COMPRESSION MACHINE

INSTALLATION QUALIFICATIONS OF COMPRESSION MACHINE TABLE OF CONTENT Purpose Scope Responsibilities Procedure Installation Qualification tests Documents & Drawings Verification Verification of Technical Specification for In-House & sub-components / Bought out items Utilities Verification Material of Construction Verification Critical Instrument calibration verification Installation Qualification Tests Status Data Analysis, Summary of IQ & Recommendations Amendment Record Conclusion … Read more

OPERATIONAL QUALIFICATIONS OF COMPRESSION MACHINE

OPERATIONAL QUALIFICATIONS OF COMPRESSION MACHINE TABLE OF CONTENT Purpose Scope Responsibilities Procedure Operational qualification tests Main Panel / Control Panel Testing Power & Communication Failure Recovery Verification Safety Features Verification Variable RPM verification Operational Qualification Tests Status List of Standard Operating Procedures Data Analysis, Summary of OQ & Recommendations Amendment record Conclusion PURPOSE To describe … Read more