cleaning-validation-protocol-for-sample

Cleaning Validation Protocol for Sample Container

Learn how to validate the cleaning procedure of sample container using spectrophotometer.

1. PURPOSE:

This is to establish the documented evidence to verify the consistent performance of the Cleaning process of Sample Container for all Spectroscopy analysis.

2. SCOPE:

This protocol is applicable to carry out the process validation of Cleaning to ensure the Sample Containers has no residues to mix up with other reagents used in QC Lab.

3. ABBREVIATION:

NA - Not Applicable

NMT - Not More Than

PPT - Parts Per Thousand

QA - Quality Assurance

QC - Quality Control

4.RESPONSIBILITY:

· It is the responsibility of Quality personnel to prepare the protocol and execute the validation process as per this protocol.

· It is the responsibility of Quality Control Manager to review the protocol.

· It is the responsibility of QA Manager to approve the protocol.

5.INTRODUCTION:

Sample Containers used for Spectroscopy analysis are subjected to Cleaning to ensure that no mix-up of the reagents occurs.

6.DOCUMENTATION:

NA

7.EQUIPMENT/ MATERIALS REQUIRED:

· Spectrophotometer

· Sample Container

· Conductivity Meter

· pH Meter

· Washing Solution

· Distilled Water

· Reagent (Coloured Reagent preferred)

8.PROCEDURE:

NEW SAMPLE CONTAINER (20mL / 50mL):

· Take a fresh new Sample Container and Rinse with Distilled water twice (Holding Time 30 Seconds)· Fill 20 mL of Distilled water in 50 mL Sample Container and measure the absorbance at 505 nm, Conductivity, pH, TDS and Salinity.

USED SAMPLE CONTAINER:

1. Take a fresh new Sample Container and Rinse with Distilled water twice (Holding Time 30 Seconds).

2. Fill 20 mL of reagent in 50 mL Sample Container and measure the absorbance at 505 nm, Conductivity, pH, TDS and Salinity.

3. After measurement, take the same Sample Container, Rinse with Distilled water twice (Holding Time 30 Seconds).

4. Fill 20 mL of distilled water in Sample Container and measure the absorbance at 505 nm, Conductivity, pH, TDS and Salinity.

5. After measurement, take the same Sample Container, Rinse with washing solution and then rinse with distilled water twice (Holding Time 30 Seconds).

6. Fill 20 mL of distilled water in Sample Container and measure the absorbance at 505 nm, Conductivity, pH, TDS and Salinity.

9.ACCEPTANCE CRITERIA:

Parameter Absorbance

at 505 nm

pH Conductivity TDS Salinity

New Sample

Container with distilled Water NMT 0.000 5.0 to 7.0 1.3 μS/cm

0.5 to 1.5

mg/L

NMT 0.05

ppt

Used Sample

Container with distilled Water NMT 0.003 5.0 to 7.0 1.3 μS/cm

0.5 to 1.5

mg/L

NMT 0.05

ppt

10.RECORD OF RESULTS:

Table 1: Result for New Sample Container containing distilled water.

New Fresh Sample Container(1)Absorbance

at 505 nm

Conductivity

(μS/cm)

pH TDS

(mg/L)

Salinity

(ppt)

1

2

3

Average

Table 2: Result for used Sample Container containing reagent.

Used Sample Container(2)Absorbance

at 505 nm

Conductivity

(μS/cm)

pH TDS

(mg/L)

Salinity

(ppt)

1

2

Average

Table 3: Result for used Sample Container containing distilled water after washing (with distilled water).

Used Sample Container(2) after

washing Absorbance

at 505 nm

Conductivity

(μS/cm)

pH TDS

(mg/L)

Salinity

(ppt)

1

2

3

Average

Table 4: Result for used Sample Container containing distilled water after washing (with distilled water and washing solution).

Used Sample Container(2) after

washing Absorbance

at 505 nm

Conductivity

(μS/cm)

pH TDS

(mg/L)

Salinity

(ppt)

1

2

3

Average

Table 5: Summary report of Sample Containers

S.No

Sample

Containers

Absorbance

at 505 nm

Conductivity

(μS/cm)

pH

TDS

(mg/L)

Salinity

(ppt)

1New Fresh

Sample

Container(1)

2Used Sample

Container(2)

3Used Sample

Container(2)

after washing-1

4Used Sample

Container(2)

after washing-2

11.SUMMARY REPORT: Measured values of Absorbance at 505 nm, Conductivity, pH, obtained for fresh Sample Container (1 & 2) were meeting the acceptance criteria, where absorbance at 505 nm of fresh Sample Container 1 containing distilled water is 0.0000 and fresh Sample Container 2 containing distilled water after washing with distilled water and washing solution is …………..

12.CONCLUSION: The Sample Container has been validated as per the protocol and it is

The overall Cleaning process is Satisfactory / Not satisfactory

Submitted by:

K.Ramachandran

Executive – Quality Control

kramachandran@biosystems.in

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