Hold Time Study for 70% v/v Iso Propyl Alcohol

Objective

To establish the hold time for 70% IPA after filtration and holding after dispensing in the respective container.

Scope

Applicable to the storage of 0.2µ filtered 70% IPA used in an aseptic area.

Justification for selection of item/equipment/process/product/system

____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Site of Study

XYZ Ltd.

Department: ___________________________

Validation Team

Production: __________________________

Quality Control: __________________________

Quality Assurance: __________________________          (Individuals to be named)

Standard operating procedure / BMR /BPR / Specification

1. Preparation and usage of disinfectant solution for the sterile area. SOP No.:_________
2. Sterilization of the equipment as per SOP No.:_______________
3. Microbiological method for Bioload study MM No.:____________
4. Filtration of disinfectant solution in the sterile area. SOP No.:________

Controls

Requirements:

1. Filtered disinfectant shall be stored into the sterilized SS pressure vessel.
2. IPA dispenser.
3. Integrity testing of the membrane filter shall be done prior to filtration and post-filtration.
4. The concentration of IPA used for the preparation of 70% IPA. A.R. Number of IPA. :__________________

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Qualification

Equipment	Code No.	Status	Checked By

Calibration

Equipment	Code No	Calibration Done on	Calibration Due on	Checked By

Training

Name of Person	Training Details	Checked By

Precaution

Safety aspects during the operation of equipment and process shall be ensured.

Validation Procedure

Validation to be carried out as per protocol no.

Acceptance Criteria

1. Integrity test of membrane filter before and after filtration shall pass.
2. For Bioload: The count shall not increase as compared to first day after transferring into the dispenser.
3.  WFI: 10cfu / 100ml.

Details of Non-Compliances

Details of Deviations (if any)

Deviations	Checked by

Details of OOS results (if any)

Out Of Specifications	Checked by

ALSO READ: SOP for Hold Time Study for Intermediates

Type of Validation

Concurrent / Revalidation validation.

Frequency

1. One exercise initially or whenever the process changes.
2. One exercise once in two years.

Result / Observation

Result of Bioload study of filtered 70% IPA :

Sample Frequency	A.R. Number	Bioload Result
O hours
12 hours
24 hours
48 hours
72 hours
96 hours

Summary of the findings of the experiment (inference)

______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Recommendation

______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Team Approval

___________                 ____________                    ______________

     Production                         Quality Control                        Quality Assurance

Review and Approval

________________                        _______________

 QUALITY ASSURANCE                                      UNIT HEAD

Annexure (if any)

Abbreviations

SOP : Standard Operating Procedure

No. : Number

OOS : Out of specification

AR Number : Analytical Reference Number

MOC : Material of construction

Ml : Millimeter

IPA : Iso Propyl Alcohol

MM : Microbial Method

% : Percent

µ : Micron

v/v : Volume/Volume

WFI : Water For Injection

SS : Stainless Steel

Cfu : Colony Forming Unit

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