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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 storage of 0.2µ filtered 70% IPA used in 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 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 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. Concentration of IPA used for preparation of 70% IPA. A.R. Number of IPA. :__________________


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 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

 

 

 



Type of Validation
Concurrent / Revalidation validation.

Frequency
  1. One exercise initially or whenever process changes.
  2. One exercise once in two year.

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 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
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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