The objective of this protocol is to lay down a procedure for carrying clean Equipment Hold time study and to establish the stabilization period for hold time for cleaned equipment or vessel of Liquid Oral facility.
This SOP is applicable for hold time study of cleaned equipments in Quality Control Laboratory
Officers / Executive – Quality Control shall be responsible to follow the procedure.
Manager- Quality Control and Head QA shall be accountable for compliance of this SOP.
6.1 CRITERIA FOR THE SELECTION OF EQUIPMENT FOR CLEANED EQUIPMENT HOLD TIME
As the Filter press is the most critical equipment (Hard to Clean) in the equipment matrix chain in Oral liquid Manufacturing procedures. Hence Filter press shall be considered for the Cleaned Equipment hold time study. Filter Press, which is to be held for the specified period will be the representative of all the equipment in Liquid Orals preparation area and the results of which will be applicable for all equipment in Oral Liquid preparation facility for Type A & Type B Cleaned Equipment Hold Time Study.
6.2 EXPERIMENTAL PLAN
- A) HOLD TIME FOR CLEANED EQUIPMENT AFTER TYPE A CLEANING
- The study for “Hold time Study of Type A cleaned Equipment” shall be extended for 24 Hrs.
- The study shall be conducted for Microbiological analysis as per plan (Table-I) after holding equipment unclean for 0 Hrs., 8 Hrs., 12 Hrs., 16 Hrs.and 24 Hrs.
7.1 SOP: Standard Operating Procedure
7.2 STP: Standard Testing Procedure
7.3 QC: Quality Control
7.4 QA: Quality Assurance
7.5 HPLC: High-Performance Liquid Chromatography
7.6 TOC: Total Organic Carbon
8.0 DISTRIBUTION LIST:
Quality assurance department
Quality control department
9.0 HISTROY OF REVISION:
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