Sampling in Cleaning Validation in Pharmaceutical Industry - Pharmaceutical Guidelines

SamplinginCleaningValidationinPharmaceuticalIndustry
Sampling in cleaning validation is a critical and important part of whole cleaning validation. Swab sampling and rinse sampling both have their own
significance.
Sampling in cleaning validation in the pharmaceutical industry has been a topic of everincreasing interest and scrutiny in recent Food and Drug
Administration FDA inspections. The validation of procedures used to clean the equipment employed during the various steps of a manufacturing process
is a clear requirement of current Good Manufacturing Practice cGMP. Such as, FDA inspectors now expect to see a functioning cleaning validation program
with appropriate documentation in place during their inspections.
The objectives of this article are to establish a broad basis for sampling in cleaning validation policy and programs and to determine the requirements,
procedures, acceptance limits, and working papers needed to support this vitally important activity.
Cleaning validation protocols should be developed, approved, and executed in accordance with the SOPs Cleaning Validation Sampling
covering these activities in place at the time. A typical cleaning validation protocol should consist of
Objective, Sampling and Testing Methodologies, and Acceptance Criteria sections.
Let us have a stepbystep explanation of sampling techniques and requirements, as well as the specific
analytical procedures to be used in the analysis of those samples. It should specify which laboratories are
to be involved in the testing and any precautions to be taken throughout the validation exercise.
A visual check should be incorporated into the cleaning assessment. The sampling technique chosen to
evaluate the effectiveness of the cleaning procedure should be swabbing, the fluid rinse of samples, or a
combination of both methods. The following sampling methods provide various levels of assurance
concerning cleaning:
Visual Inspection
Active product contact parts of the equipment are individually examined wherever possible for cleanliness. This visual inspection allows the early
localization and identification of any inadequacies in the cleaning procedure.
Rinse water sampling and analysis

According to 2004 FDA Guide to Inspections Validation of Cleaning Processes: Two advantages of using rinse samples are that a larger surface area may
be sampled, and inaccessible systems or ones that cannot be routinely disassembled can be sampled and evaluated.
1. Analysis can be quantitative, using pH, conductivity, particle count, microbial count, Total Organic Carbon TOC determination, spectrophotometry,
bioassays, or limulus amebocyte lysate for pyrogens.
2. Recovery factor is uncertain; it involves dilution.
Surface sampling and analysis

1.Removes adherent materials.
2. Analysis can be quantitative.
3. The Precise definition of the area sampled is required.
Method Selection
Whenever possible, each piece of equipment should be dismantled into its individual components after cleaning and each part should be individually tested
for cleanliness. In this manner, any inadequacies in the cleaning process will be more readily identified and localized.
It may not be practical or desirable to dismantle large or CleanInPlace CIP equipment. Regardless, validation sampling and testing should commence as
soon as possible after the cleaning process is complete to reduce the chance of contamination by outside sources. Equipment that has just been cleaned
should be covered immediately by appropriate means to protect it from any contamination.
Solvents
Aqueous or organic solvents used in the cleaning procedure should be sufficient to remove residues, and at the same time, should be minimized to reduce
the risk of reaction with or damage to the equipment, or the overdilution of the residue and the resultant loss of analytical sensitivity.
Samples should be collected in clean or sterile containers. Sterile containers are suitable for this intended use. All validation samples must be properly
labeled with complete information regarding the source of the sample, samplers name, sampling date, reference number, product name, and the part of
equipment from which the sample has been collected.
A sample of the rinse or swabbing solvent should always be included with the actual test samples to serve as a reagent blank for any chemical or
microbiological determination when required.
All types of samples, physical, chemical, or microbiological, should be collected according to a written procedure and using techniques, reagents,
equipment, and containers appropriate to the type of testing to be performed. Only trained personnel should perform the collection of these samples.
The environmental effectiveness of cleaning procedures should be assessed by the surface sampling of nonproduct contact surfaces e.g.: floors, walls, air
ducts, exterior equipment surfaces, etc.. Samples should be collected and analyzed for potential contamination.
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widelyread pharmaceutical
blog since 2008. Signup for the free email updates for your daily dose of pharmaceutical tips.
Need Help: Ask Question
Online
20082017 All rights reserved to Ankur Choudhary and data may not be reproduced on other websites. Designed by Pharmaceutical Guidelines.
Privacy Policy Disclaimer

Sampling in Cleaning Validation in Pharmaceutical Industry - Pharmaceutical Guidelines

Uploaded by

Copyright:

Available Formats

Sampling in Cleaning Validation in Pharmaceutical Industry - Pharmaceutical Guidelines

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Sampling in Cleaning Validation in Pharmaceutical Industry - Pharmaceutical Guidelines

Uploaded by

Copyright:

Available Formats

SamplinginCleaningValidationinPharmaceuticalIndustry

Rinse water sampling and analysis

Surface sampling and analysis

You might also like