HOLD TIME STUDY PROTOCOL

OF
CLEANED MANUFACTURING EQUIPMENT
AWAITING FOR USE

COMPANY NAME

DOCUMENT NUMBER :

ISSUE DATE :
 HOLD TIME STUDY PROTOCOL OF
CLEANED MANUFACTURING EQUIPMENT AWAITING FOR USE

Protocol No. : XXXXXXXX Issue Date : XXXXXXX

Version No : 00 Page No. : Page 2 of 11

TABLE OF CONTENTS

1. PREAPPROVAL....................................................................................................................................................03

2. OBJECTIVE......................................................................................................................... 04

3. SCOPE................................................................................................................................. 04

4. RESPONSIBILITIES............................................................................................................. 04

5. EXECUTION PLAN…..........................................................................................................05

6. DOCUMENTATION OF THE VALIDATION EXPERIMENT....................................................06

7. REVIEW OF TEST RESULTS .............................................................................................08

8. EXECUTIVE SUMMARY......................................................................................................09

9. REPORT APPROVAL.......................................................................................................... 10

10. GLOSSARY......................................................................................................................... 10
 HOLD TIME STUDY PROTOCOL OF
CLEANED MANUFACTURING EQUIPMENT AWAITING FOR USE

Protocol No. : XXXXXXXX Issue Date : XXXXXXX

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1.0 PREAPPROVAL:
1

The pre-approval of this Hold Time Study Protocol shall be the joint responsibility of the
following:

_______________________________ _____________

Date
Head Production

_______________________________ ___________
Date:
Officer Quality Control

_________________________________ ___________
. Date:
Executive Quality Assurance

_______________________________ ___________
Date:
Works Manager

__________________________________ ____________

. Date:
Manager – Corporate Quality System
 HOLD TIME STUDY PROTOCOL OF
CLEANED MANUFACTURING EQUIPMENT AWAITING FOR USE

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2.0 OBJECTIVE:

The protocol is intended to prove with a high degree of confidence, by providing the
suitable documented evidence for hold time study of Cleaned Manufacturing Equipment
awaiting for use.

The cleaned Manufacturing equipments with hold time for minimum 3 days do not have
effect on quality attributes.

3.0 SCOPE
The protocol shall specify the responsibilities for the activities related to Hold Time
Study.
The sampling and testing plan shall explained in this protocol and shall be executed in
order to achieve the objective

4.0 Responsibilities

Quality Assurance:

Quality Assurance (QA) Head is responsible for preparation, checking and approval of
Hold Time Validation protocol. He is also responsible to ensuring execution, verification
of proper sampling and testing activities, and review of study data .He is responsible for
final review and approval of the Hold Time Study report. Quality Assurance Officer is
responsible for sampling of the samples at the specified stages of the study. Quality
Assurance Officer is responsible for recording for temperature and humidity of the
concern area. Executive Quality Assurance is responsible for checking and verification
related to storage conditions monitoring during Hold time.

Quality Control
 HOLD TIME STUDY PROTOCOL OF
CLEANED MANUFACTURING EQUIPMENT AWAITING FOR USE

Protocol No. : XXXXXXXX Issue Date : XXXXXXX

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The Quality Control personnel are responsible for testing and release of the samples at
the specified stages of the study.

The Hold Time Study shall comprise of the following team members.

NAME OF PERSON DEPARTMENT DESIGNATION

5.0 EXECUTION PLAN :

Initiation Date : _______________

Completion Date : _______________

Keep aside cleaned manufacturing equipments in clean and dry polybags in a proper
place intended for storage. Analyze the manufacturing equipment on 1st day for microbial
limit test.
Hold the cleaned manufacturing equipment for a period of 3 days under proper storage
conditions.
At the end of 1st day, 2nd day and 3rd day again analyze the manufacturing equipment for
microbial limit test and compare the results.
 HOLD TIME STUDY PROTOCOL OF
CLEANED MANUFACTURING EQUIPMENT AWAITING FOR USE

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5.1 Sampling Plan :

Take the swab 100 cm2 of the manufacturing equipment and place it in a sterile tube .

Equipment Sampling Locations

1. Discharge Valve
Vibratory Sifter
2. Edges of Sieve
Binder Preparation Vessel 1. Bowl of Binder Preparation Vessel
IPC Container 1. Discharge Valve
1. Base of Chopper
Saizoner Mixer Granulator
2. Base of Mixer
1. Edges of sieve of FBD bowl
2. View Glass of Bowl
Fluidized Bed Drier
3. View Glass of Body
4. Rim of the Sieve of Bowl
1. Sieve of Sifter
Sifter cum Multimill
2. Sieve of Multimill
Conta Bin 1. Discharge Valve
Tippler 1. Discharge Valve
1. Hopper 1
2. Hopper 2
3. Forced Feeder 1
4. Force Feeder 2
Compression Machine
5. Turret
6. Deduster 1
7. Deduster 2
8. Chute
1. Baffle
Auto-Coater
2. Pan
Coating Solution Preparation Vessel 1. Coating Vessel
1.Sieve of Grinding slit
Colloidal Mill
2. Hopper
1. Hopper
Blister Machine 2. Disc
3. Nozzle of Hopper
1. Hopper
Strip Sealing Machine 2. Disc
3. Nozzle of Hopper
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Protocol No. : XXXXXXXX Issue Date : XXXXXXX

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Before taking the swab sampling verify that the equipment is visually clean to the eye and it
should be free from traces of previous product.
Label the samples appropriately after taking the swab.

5.2 Description of the Experiment:

1. Determine the microbial count of the Manufacturing equipment.

5.3 Microbial Procedure:

Sr. No Test Acceptance criteria Reference

1. Visual observation Clean to Eye. Inhouse

Microbial Limit Test:

2. Total Aerobic Microbial NMT 100 cfu / 100 cm2 Inhouse
Count

DESCRIPTION OF THE EXPERIMENT:

Carry out a visual inspection & microbiological examination for cleaned manufacturing
equipment.
The samples should be tested for total microbial count as a microbiological examination.

6.0 DOCUMENTATION OF THE VALIDATION EXPERIMENT

Sampling details and microbiological results of the validation experiment are

documented respective protocol.
 HOLD TIME STUDY PROTOCOL OF
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Protocol No. : XXXXXXXX Issue Date : XXXXXXX

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7.0 REVIEW OF TEST RESULTS:

The following table summarizes of visual inspection & microbiological examination

manufacturing equipment for hold period time of 3 days.
Equipments after Cleaning and Awaiting for Use

( Meets Acceptance Criteria Yes / No )

Manufacturing SUMMARY OF VISUAL SUMMARY OF MICROBIO –
Equipments INSPECTION LOGICAL EXAMINATION
INITIAL 1st 2nd 3rd INITIAL 1st 2nd 3rd
DAY DAY DAY DAY DAY DAY DAY DAY
Vibratory Sifter
Binder Preparation Vessel
IPC Container
Saizoner Mixer Granulator
Fluidized Bed Dryer
Sifter cum Multimill
Conta Bin
Tippler
Compression Machine
Auto-Coater
Coating Solution
Preparation Vessel
Colloidal Mill
Blister Machine
Strip Sealing Machine
Report Report Report Report Report Report Report Report
Reference No.: No.: No.: No.: No.: No.: No.: No.:

Date
 HOLD TIME STUDY PROTOCOL OF
CLEANED MANUFACTURING EQUIPMENT AWAITING FOR USE

Protocol No. : XXXXXXXX Issue Date : XXXXXXX

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Remark:

______________________________________________________________________

______________________________________________________________________

______________________________________________________________________

______________________________________________________________________

______________________________________________________________________

______________________________________________________________________

______________________________________________________________________

______________________________________________________________________

______________________________________________________________________

Checked By: ________________________ Date: ___________________

Reviewed By: ________________________ Date: ___________________

8.0 EXECUTIVE SUMMARY:

Note: Use additional pages if required.

______________________________________________________________________

______________________________________________________________________

______________________________________________________________________

______________________________________________________________________
 HOLD TIME STUDY PROTOCOL OF
CLEANED MANUFACTURING EQUIPMENT AWAITING FOR USE

Protocol No. : XXXXXXXX Issue Date : XXXXXXX

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______________________________________________________________________

Written By: ________________________ Date: ___________________

Approved By: ______________________ Date: ___________________

9.0 REPORT APPROVAL:

_______________________________ ___________

Date
Head Production

_______________________________ ___________
Date:
Officer Quality Control

_________________________________ ___________

Date:
Executive Quality Assurance

_______________________________ ___________

. Date:
Works Manager

__________________________________ ____________
Date:
Manager – Corporate Quality System

10.0 GLOSSARY:

GLOSSARY
CFU’S Colony Forming Units
cm Centimeter
CME Cleaned Manufacturing Equipment
HTS Hold Time Study
QA Quality Assurance
QC Quality Control
 HOLD TIME STUDY PROTOCOL OF
CLEANED MANUFACTURING EQUIPMENT AWAITING FOR USE

Protocol No. : XXXXXXXX Issue Date : XXXXXXX

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