Hold Time Study of 70% Ipa

Golden Cross Sikkim

HOLD TIME STUDY PROTOCOL Protocol No.: HTSIPA Version No.: 01

Date of Issue: HOLD TIME STUDY FOR 70% v/v ISO PROPYL ALCOHOL AFTER FILTRATION

Supersedes: ----1.0

Objective

Effective date: Page 1 of 5

:

To establish the hold time for 70% IPA after filtration and holding after dispensing in the respective container. 2.0

Scope

:

Applicable to storage of 0.2µ filtered 70% IPA used in aseptic area. 3.0

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

4.0

Site of study

:

Golden Cross, Sikkim Department : ___________________________ 5.0

Validation Team

: Production

: __________________________

Quality Control

: __________________________

Quality Assurance : __________________________ (Individuals to be named) 6.0

Standard operating procedure / BMR /BPR / Specification

:

6.1

Preparation and usage of disinfectant solution for sterile area. SOP No.:___________

6.2

Sterilization of the equipment as per SOP No.:____________

6.3

Microbiological method for Bioload study MM No.:_________

6.4

Filtration of disinfectant solution in sterile area. SOP No.:___________

Golden Cross Sikkim

HOLD TIME STUDY PROTOCOL Protocol No.: HTSIPA Version No.: 01

Date of Issue: HOLD TIME STUDY FOR 70% v/v ISO PROPYL ALCOHOL AFTER FILTRATION

Supersedes: -----

7.0

Controls 7.1

Effective date: Page 2 of 5

:

Requirements

:

7.1.1 Filtered disinfectant shall be stored into the sterilized SS pressure vessel. 7.1.2 IPA dispenser . 7.1.3 Integrity testing of the membrane filter shall be done prior to filtration and post filtration. 7.1.4 Concentration of IPA used for preparation of 70% IPA. A.R. Number of IPA. :__________________ 7.2

Qualification

:

Equipment

7.3

Calibration

Training

Code No

Checked by

Calibration Done on

Calibration Checked Due on by

: Name of Person

7.5

Status

:

Equipment

7.4

Code No.

Precaution :

Training Details

Checked By

Golden Cross Sikkim

HOLD TIME STUDY PROTOCOL Protocol No.: HTSIPA Version No.: 01

Date of Issue: HOLD TIME STUDY FOR 70% v/v ISO PROPYL ALCOHOL AFTER FILTRATION

Supersedes: -----

Effective date: Page 3 of 5

Safety aspects during operation of equipment and process shall be ensured. 8.0

Validation Procedure

:

Validation to be carried out as per protocol no. NRVPHTIPA, Version No.: 01 9.0

Acceptance Criteria

:

9.1

Integrity test of membrane filter before and after filtration shall pass.

9.2

For Bioload: The count shall not increase as compared to first day after transferring into the dispenser.

9.3 10.0

WFI: 10cfu / 100ml.

Details of Non Compliances 10. 1 Details of Deviations (if any)

:

Deviations

10.2

Details of OOS results (if any) : Out Of Specifications

11.0

Type of Validation : Concurrent / Revalidation validation.

12.0

13.0

Checked by

Frequency

:

12.1

One exercise initially or whenever process changes.

12.2

One exercise once in two year.

Result / Observation

:

Checked by

Golden Cross Sikkim

HOLD TIME STUDY PROTOCOL Protocol No.: HTSIPA Version No.: 01

Date of Issue: HOLD TIME STUDY FOR AFTER FILTRATION

Supersedes: ----13.1

Effective date:

70% v/v ISO PROPYL ALCOHOL

Page 4 of 5

Result of Bioload study of filtered 70% IPA : Sample Frequency O hours 12 hours 24 hours 48 hours 72 hours 96 hours

A.R. Number

Bioload Result

14.0

Summary of the findings of experiment (inference) :

15.0

Recommendation :

16.0

Team Approval :

__________________ Production Date : 17.0

Review and Approval:

__________________ Quality Control

___________________ Quality Assurance

Golden Cross Sikkim

HOLD TIME STUDY PROTOCOL Protocol No.: HTSIPA Version No.: 01

Date of Issue: HOLD TIME STUDY FOR 70% v/v ISO PROPYL ALCOHOL AFTER FILTRATION

Supersedes: -----

_______________________ QUALITY ASSURANCE

Effective date: Page 5 of 5

___________________ UNIT HEAD

Date : 18.0

Annexure (if any) :

19.0

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