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Hold Time Study of Cleaned Equipments
Hold Time Study of Cleaned Equipments
Learn how to validate the cleaned equipments of Production for Hold Time and Its Protocol.
1. OBJECTIVE
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.
2. SCOPE
This protocol is applicable to the worst case considered in cleaning validation for cleaned Equipment Hold Time Study of the equipment used in the
manufacturing of various products in Liquid orals facility, This protocol shall also define the responsibility, equipment details, sampling method,
sampling plan and acceptance criteria for equipment hold time study.
3. PURPOSE OF STUDY
The purpose of this protocol shall be extended to establish hold time for a Type A & Type B cleaned equipment by:
A. Studying the Microbial Load after holding it uncleaned for the specified time period. This study is applicable only to manufacturing equipment
which is Type A cleaned.
B. Type ‘B’ cleaning shall be carried out immediately after the completion of specified hold time period and chemical and microbial analysis data shall
be collected for the same. Evaluate results of above study for both Chemical & Microbial contamination against cleaned (Type B cleaning) equipment
to understand the level of contamination to decide effective cleaning methodology.
4. RESPONSIBILITY
The validation group comprising of representatives from each of the following departments shall be responsible for the overall compliance with this
protocol
5. 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. EXPERIMENTAL PLAN
TABLE-I
SAMPLING PLAN(Type A Cleaned Equipment)
Sl. No. Hold Time Study Sampling Time Test to be Performed Acceptance Criteria
01. 0 Hrs. Sampling to be done immediately after use. Microbial
To monitor & Establish
02. 8 Hrs. Sampling to be done immediately after 8 Hrs. of use. Microbial
Limit for Microbial counts.
03. 12 Hrs. Sampling to be done immediately after 12 Hrs. of use. Microbial
After Type -B Sampling to be done immediately after Type B Cleaning for NMT 10 (ppm./ 4 inch2.)
06. Chemical
Cleaning Chemical
TABLE-II
SAMPLING PLAN (Type B Cleaned Equipment)
Sl. No. Hold Time Study Sampling Time Test to be Performed Acceptance Criteria
7. STORAGE
The Cleaned Equipment shall be stored properly in the area dedicated to the storage of Type A cleaned equipment.
8. SWAB SAMPLING
Swab samples shall be taken as per the standard operating procedure, after the final cleaning of the equipment once the equipment qualifies the
visual inspection test.
Collected swab samples shall be transferred to QC for further Microbial & Chemical analysis
SWAB sampling (for CHEMICAL ANALYSIS)
Swab samples shall be taken as per the standard operating procedure and should be analyzed within 4 hours of sampling.
9. ACCEPTANCE CRITERIA
i) MICROBIAL DETERMINATION
During the specified holding period, the Total Bacterial Count shall be monitor & establish per swab and Total Fungal Count (yeasts & moulds) shall
be Nil per swab.
ii) CHEMICAL DETERMINATION
The residue content detected in each swab collected shall be below the acceptance limits derived, for type B cleaning.
Acceptance Limit for chemical determination: Not more than 10 PPM / Swab.
12. CONCLUSION
On the basis of the evaluated results, a conclusion shall be drawn to state Type A & Type B cleaned Equipment holding time-based on the result
obtained for the various studies carried out as per the methodology is given in this protocol.
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read
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