Cleaning Validation Protocol for Sample Container

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 (Colored 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 the 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.

Related: Ultraviolet and Visible Absorption Spectrophotometer (Apparatus and Calibration)

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)
1	New Fresh Sample Container(1)
2	Used Sample Container(2)
3	Used Sample Container(2) after washing-1
4	Used 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  

Also see:

• Cleaning Validation of Pharmaceutical Equipments
• Cleaning Validation in Pharmaceuticals
• Cleaning Validation Sample Protocol
• Cleaning Validation Protocol for Pharmaceuticals

Submitted by:

K.Ramachandran

Executive – Quality Control

kramachandran@biosystems.in

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