Cleaning Validation, Validation Engineering

How Clean is Clean

Cleaning Validation Approach in Medical Devices

The cleaning processes play a very important part of the manufacturing of medical devices.

Chemicals that take part in the manufacturing of medical devices, (Mold release agents, Finishing Media, Coolants, etc.) are an integral part of the process but pose a threat if not removed properly.

You can use a matrix to select the highest risk devices where to be studied. This selection divided all of the products manufactured into three main families that may include for example:

Sterile Implantable Devices
Sterile Devices
Non Sterile Devices

Make an exhaustive identification of components cleaned at your facilities and chemicals associated with manufacturing these components in order to select a worst-case scenario for both components and contaminants. After completing this selection, a validation plan shall be prepared including the necessary test method validations for the Critical Quality Attributes (CQAs) to be validated.

A Material Characterization shall be done for each contaminant in order to identify it within cleaned samples.

In order to validate the robustness of our cleaning processes, a recovery test method validation had to be performed using the worst-case components including organic and inorganic contaminants present in manufacturing.

The samples for each component can be obtained from the actual cleaning process.

In each cleaning run, each sample shall be inspected 100 % visually in order to verify its cleanliness, and then a certain quantity of samples is retrieved for organic and inorganic residuals, endotoxins, cytotoxicity, and bioburden tests.

The acceptance criteria of organic and inorganic compounds can be based on the maximum exposure limit for each contaminant.

For endotoxin, cytotoxicity, and bioburden the acceptance criteria can be applied using available standards.

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WHAT IS CLEANING VALIDATION?

WHY CLEANING VALIDATION?

WHEN IS REQUIRED A CLEANING VALIDATION?

HOW TO PREPARE A VALIDATION PROTOCOL IN 24 STEPS?

12 ELEMENTS TO CONSIDER DURING A SUCCESSFUL CLEANING VALIDATION

HOW TO WRITE A CLEANING PROCESS PROCEDURES IN 6 STEPS.

THE TOP ANALYTICAL METHODS USED

PREFERRED TEST METHODS

CONSIDERATIONS TO SELECT THE CORRECT TEST METHOD

SAMPLING

TOP CLEANING VALIDATION FACTORS AND LEVELS

ESTABLISHMENT OF ACCEPTABLE CRITERIA

FDA EXPECTATIVE TO CLEANING VALIDATION 21 CFR 211.67

STATUTORY AND REGULATORY REQUIREMENTS

More details on specific FDA expectations can be found in the guidance document below.

httpss://www.iso.org/standard/53394.html

For a preview, refer to httpss://www.iso.org/obp/ui/#iso:std:iso:14644:-1:ed-2:v1:en

Three (3) options to create a qualification protocol:

Option 1. You can create a great protocol, using a template.

You can download a free sample of a validation template in .pdf format.

To see the complete list of the most popular validation templates, click here.

In addition, you can request a quotation to buy online a full validation template document in MS Word format that is completely editable, ready to fill, and adapt to your needs.

Option 2. We can bring you a formal training on how to create your own validation protocols using our template(s).

This option is recommended if you want to learn more about how to build a robust validation protocol. One of our expert(s) will provide online step-by-step training to your team (unlimited assistance) on how to build a reliable validation protocol using a template. You can improve your corporate validation procedures and policies incorporating our template sections. It includes the template, an exam, and a training certificate for each assistant. Request a quote now.

Option 3. We can create a customized qualification.

One of our expert(s) will create and prepare for you a customized validation protocol with the inputs and specific information of your company. It may include, online support in document creation, execution, or final reporting, Request a quote online.

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References

PIC/S Guideline to Validation – PI -006-3 (2007)

ICH Guideline Q7 “GMP for APIs

Inspection Guide for Bulk Pharmaceutical Chemicals and the Biotechnology Inspection Guide

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=225.1

httpss://www.fda.gov/validation-cleaning-processes-793

httpss://www.fda.gov/drugs/guidances-drugs/questions-and-answers-current-good-manufacturing-practices-equipment

httpss://www.gmp-compliance.org/gmp-news/what-does-the-fda-expect-from-cleaning-validation-today

httpss://gmpnews.net/2019/06/fda-requirements-for-cleaning-validation/

httpss://www.pda.org/docs/default-source/website-document-library/chapters/presentations/australia/contamination-control-cleaning-validation.pdf?sfvrsn=4

Ramon Cayuela, MS, BS, Chemical Engineering

CIQA President and CEO.
I've been working in validation engineering since 1992 with many multinational pharmaceutical companies. I love sharing my passion and knowledge with others. If you have any questions about anything (or just have general questions). I will be more than happy to assist you. You can count on the BEST customer service on CIQA. I go to great lengths to make sure my clients are 100% satisfied with their purchases and check emails/messages consistently throughout the day. You can rest assured that everything being sold here is as-described or your money back. I look forward to working with you!