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

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

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.:________

  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. :__________________



Code No.


Checked By











Code No

Calibration Done on

Calibration Due on

Checked By






















Name of Person

Training Details

Checked By










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)


Checked by




Details of OOS results (if any)

Out Of Specifications

Checked by




Type of Validation
Concurrent / Revalidation validation.

  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)


Team Approval

___________                 ____________                    ______________
     Production                         Quality Control                        Quality Assurance

Review and Approval

________________                        _______________
 QUALITY ASSURANCE                                 UNIT HEAD

Annexure (if any)

SOP : Standard Operating Procedure
No. : Number
OOS : Out of specification
A.R.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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