OBJECTIVE:
To lay down the procedure for preparation and usage of 70% IPA solution.
SCOPE:
This SOP is applicable to the procedure for preparation and usage of 70% IPA solution.
RESPONSIBILITY:
Initiator Officer/Designee: Production shall perform the operation activity as per SOP.
Initiator Executive/Designee: Production shall ensure the compliance of the SOP.
ACCOUNTABILITY:
QA Head shall be Accountable for implementation of SOP.
ABOUT 70% IPA
70% IPA solution is a powerful antimicrobial agent that effectively kills microbes through a multi-pronged mechanism:
- Protein Denaturation: IPA disrupts the structure of proteins, causing them to unfold and lose their function. This is crucial for microbes as proteins are essential for their structure, metabolism, and reproduction.
- Cell Membrane Disruption: IPA dissolves the lipid bilayer of microbial cell membranes, compromising their integrity. This leads to leakage of cellular contents and ultimately cell death.
- Inhibition of Metabolism: By disrupting proteins and cell membranes, IPA interferes with essential metabolic processes within the microbe, further contributing to its demise.
The 70% concentration is optimal as it allows for efficient penetration of the microbial cell wall while also slowing down evaporation, ensuring prolonged contact time for effective action.
PROCEDURE:
Indent shall be raised by production executive and authorized by QA to the RM store, on Miscellaneous materials issue request.
Transfer the dispensed quantity of IPA from dispensed RM hold to the respective production area.
The required quantity of IPA & Purified water shall be measure by using the measuring cylinder as per below example.
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https://pharmaguidehub.com/product/preparation-and-usage-of-70-ipa-solution/
Example: 7.0 litre of IPA & 3.0 litre of water shall be taken for preparation of the 70% IPA.
Pour the calculated quantity of IPA and Purified water in to the SS container. Stir the solution properly by using Cleaned SS paddles for 5 minutes.
Closed the lid of the container and enter the details in label.
Measure the total quantity of prepared 70%IPA solution and enter the details in the Log Sheet as per the Format –1.
Do not keep open the lid of the solution container.
70% IPA Solution to be used with in the seven days from the day of preparation & affix the label as per format -II.
REFERENCES:
Not Applicable
ANNEXURES:
| Annexure Number | Title of annexure |
| Annexure-I | 70% IPA Preparation and Usage Log sheet |
| Annexure-II | 70% IPA For cleaning purpose |
ENCLOSURES: SOP Training Record.
DISTRIBUTION:
- Controlled Copy No. 01 : Head Quality Assurance
- Controlled Copy No. 02 : Head Production
- Master Copy : Quality Assurance Department
ABBREVIATIONS:
| PD | : | Production |
| No. | : | Number |
| SOP | : | Standard Operating Procedure |
| BMR | : | Batch manufacturing record |
| HDPE | : | High density polyethylene |
| IPQA | : | In process Quality Assurance |
REVISION HISTORY:
CHANGE HISTORY LOG
| Revision No. | Details of Changes | Reason for Change | Effective Date |
| 00 | New SOP | Not Applicable | To Be Written Manual |
Annexure-I
70% IPA Preparation and Usage Log sheet
Annexure-II
70% IPA For cleaning purpose
Click the link to download word file copy of this document:
https://pharmaguidehub.com/product/preparation-and-usage-of-70-ipa-solution/
