GLASSWARE CLEANING VALIDATION

admin

2 years ago

GLASSWARE CLEANING VALIDATION

Name of Product	GLASSWARE CLEANING VALIDATION
Parameter	GLASSWARE CLEANING VALIDATION
Method followed	BY UV
Supersede No.	Nil
Total No of pages
Effective Date

Sr. No.	Title	Page
—	Product Description
—	Table of contents
1.0	Document Preparation and Protocol Approval
2.0	Revision Control History
3.0	Objective
4.0	Scope
5.0	Reason For Validation
6.0	Responsibility
7.0	Description of Method Belonging
8.0	Training Details
9.0	Glassware Cleaning Validation
10.0	Cleaning glassware
11.0	Preparation of Solution
12.0	Procedure
13.0	Erumpent/ Instrument Required during Validation
14.0	Acceptance criteria
15.0	References

DOCUMENT PREPARATION AND PROTOCOL APPROVAL

Preparation and Approval of this Cleaning Validation document will be joint responsibility of the following functional area. Any modification in this document shall be documented and approved

Prepared By:

Name	Designation	Signature	Date
	Executive – QC

Reviewed By:

Name	Designation	Signature	Date
	Executive – QC
	Manager – QC

Approved By:

Name	Designation	Signature	Date
	Head – QA

Revision Control History:

Effective Date	Version no.	Superseded no.	CCF no.	Reason for Review
	00	Nil	NA	New documents

OBJECTIVE:

To perform Glassware Cleaning Validation provides documentary evidence that the method used for Glassware Cleaning Validation of said product full fill the regulatory & compendia requirement. This protocol presents and discusses the result obtained in the Validation study.

4.0 SCOPE:

This document is applicable for the Glassware Cleaning Validation of UV Method which is applying at ABC Company

5.0 REASON FOR VALIDATION:

Regulatory Requirement

6.0 RESPONSIBILITY:

The following functions are involved in the Analytical method Validation performing and shall carry out the following responsibilities.

6.1 Quality Control:

6.1.1 Officer & Executive Quality Control: To perform the analysis in the Verification and evaluate the data as per protocol.

6.1.2 Sr. Officer: To prepare the protocol and review all data evaluated as per protocol.

6.1.3 Manager Quality Control: To provide technical support, review the protocol and ensure that all parameter performed as per protocol.

6.2 Regulatory:

6.2.1 To provide technical support, review and approved the protocol and ensure that all parameter performed as per protocol.

7.0 DESCRIPTION OF METHOD BELONGING:

7.1 Product Detail:

7.1.1 Name of Product: GLASSWERE CLEANING VALIDATION

7.1.2 Generic Name: GLASSWERE CLEANING VALIDATION

7.2 Method Details:

Methodology: UV

8.0 TRAINING DETAILS:

Training shall be imparted to all concern persons involved in Glassware cleaning validation activity w.r.t. cGMP

and concerned analytical technique required for analysis and details will be attached in Glassware cleaning

validation report’ activity, as per below mentioned format.

Purpose	To train all personnel involved in the execution of this protocol
Topic	· Purpose · Procedure · Method details · Acceptance criteria · Documentation etc.
S. No.	Name of Participants	Trainees area of concern	Sign/Date

DETAILS OF GLASSWERE CLEANING VALIDATION
10.0 Preparation of cleaning solutions
10.1 For the cleaning of glassware, those are used for chemical analysis special precautions will take place to avoid any chemical residue in glassware, which may later interfere with the results of chemical analysis.
Following cleaning solutions were used for cleaning of glassware.
10.2 2% Liquid soap solution
10.2.1 Measure 20 ml soap solution and add it to container containing 980 ml of purified water and stir it well.

10.2.2 Record the solution preparation details in glassware cleaning solution preparation record.

10.3 Cleaning glassware

10.3.1 Cleaning of glassware, which has contained hazardous materials, must be solely undertaken by experienced personnel.

10.3.2 Most new glassware is slightly alkaline in reaction. For precision chemical tests, new glassware should be soaked several hours in acid water (1% solution hydrochloric acid or nitric acid) before washing.

10.3.3 Wash glassware as quickly as possible after use if it is not possible then the articles should be allowed to soak in water.

10.3.4 For cleaning of glassware such as bottles, flasks, beakers, test tubes, etc use 2% liquid soap solution. For better results use hot water.

10.3.5 During the washing all parts of the article should be thoroughly scrubbed with a brush selected for the shape and size of the glassware. Brushes should always be in good condition to avoid any abrasion of the glassware.

10.3.6 Special types of precipitate material may require removal with nitric acid, aqua regia or fuming sulphuric acid. These are very corrosive substances and should be used only when required.

10.3.7 Before cleaning of glassware remove the labeling of marker pen with the help of IPA or acetone. For plastic ware do not use acetone for removing marker pen labeling.

10.3.8 It is imperative that all soap detergent and other cleaning fluids be removed from glassware before use. This is especially important with detergents, slight traces of which will interfere with serological and culture reactions.

10.3.9 After cleaning, thoroughly rinse with tap water ensuring that containers are partly filled with water, shaken and emptied several times. Finally rinse with purified water.

10.3.10 After cleaning dry the glassware in Hot air oven at 600 temperature ± 50.

10.3.11 Always protect clean glassware from dust by use of temporary closures or by placing in a dust free cabinet

11.0 Type of Analysis: BY UV
11.1 Preparation of Solutions:
11.2 Blank Solution Preparation:
11.3 Sample Solution Preparation:
11.5 For Blank Samples:
The Purified water as a blank scans for 200nm to 400 nm riding to UV Spectrophotometer.

11.6 For Glassware Rinse Samples:
After dry the Glassware cleaning for purified water (rinse sample) scan for 200 nm to 400 nm riding to UV Spectrophotometer.

The glassware cleaning sample absorbance not more than blank sample absorbance.

11.7 Procedure:
Switch on the main power supply
After getting the initialization of instrument About 15 minutes, instrument Triple beep sound.
Than Press enter and again sound of tree beep, Open the software on system UV-Visible analyst display on the system screen.
Display system status, close click on file menu, click new and select fixed point measurement for single wavelength and multiple wavelengths.
Click on file menu, click new and select Wavelength scan measurement for scanning.
For scan click wavelength scan measurement fill up the blank medium in booth cuvette and click z for both cuvette matching.
Then fill sample in sample cuvette and click red arrow.

11.8 Equipment/Instrument required during validation

Sr. No.	Name of Equipment	Equipment No.	Calibration Status		Make/Model
			Calibration on	Calibration Due
1.	UV Spectrophotometer

11.9 Reagents and Chemicals

Sr. No.	Name of Reagent	Grade	Make	Lot No.
1.	WATER
2.	ph paper strips

12.0 ACCEPTANCE CRITERIA

Sr. No.	Title	Acceptance Criteria	Observations/Conclusions
1.	ABSORBANCE	The glassware cleaning sample absorbance not more than blank sample absorbance.