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Cleaning Validation - Lab Services - QbD Group

Cleaning Validation

Effective cleaning, safeguarding patient safety

Cleaning validation is a cornerstone of patient safety and product quality. At QbD Group, we help you define and implement best practices for cleaning validation, ensuring compliance with industry standards and regulatory requirements. Our expertise and tailored solutions make cleaning validation a seamless part of your quality control processes.

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What is cleaning validation?

Cleaning validation is a documented process that ensures manufacturing equipment is free from residues of previous products, cleaning agents, or microbial contaminants. It confirms that cleaning procedures consistently result in acceptable levels of cleanliness, protecting both patient safety and product integrity. Key components include:

  • Residue analysis: Detecting active pharmaceutical ingredients (APIs) and cleaning agent residues.

  • Swab testing: Sampling surfaces to verify cleanliness, covering chemical and microbiological residues.

  • Analytical method validation: Ensuring methods can accurately detect contaminants in the parts-per-million (PPM) range.

  • Protocols and reporting: Developing comprehensive cleaning validation plans and protocols with clear documentation.

Discover why cleaning validation is essential

Cleaning Validation - Lab Services - QbD Group (1)

Why is cleaning validation essential?

Effective cleaning validation is critical for:

 

  • Patient safety: Eliminates risks of cross-contamination, ensuring safe and effective products.
  • Regulatory compliance: Meets stringent industry and regulatory standards.
  • Product integrity: Maintains product quality by preventing contamination from previous batches or cleaning agents.
  • Operational efficiency: Identifies potential cleaning process inefficiencies, optimizing resource use.
  • Global market access: Demonstrates compliance with international standards, facilitating worldwide distribution.

 

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How can we help?

At QbD Group, we offer a comprehensive range of cleaning validation services:

Residue analysis

Residue analysis

Precise detection of API residues and cleaning agents in the PPM range.

Swab sample analysis

Swab sample analysis

On-site support for swab sampling, covering both chemical and microbiological residues.

Validation of analytical methods

Validation of analytical methods

Development and validation of methods to ensure reliability and accuracy.

Protocol development and reporting

Protocol development and reporting

Creating and managing cleaning validation protocols with complete study reporting.

On-site assistance

On-site assistance

Hands-on support for swab sample collection and validation setup.

Cleaning Validation - Lab Services - QbD Group (2)

Why partner with QbD Group?

Here’s why QbD Group is your trusted partner for cleaning validation:

  • Extensive expertise: Years of experience in cleaning validation across regulated industries.

  • Regulatory knowledge: Deep understanding of global regulatory requirements and standards.

  • Tailored solutions: Customized cleaning validation strategies for your specific processes and needs.

  • Comprehensive support: End-to-end assistance, from protocol creation to final reporting.

  • State-of-the-art methods: Cutting-edge analytical capabilities for precise residue detection.

  • QbD Group has a GMP license, an ISO 17025 certificate and is audited by the Belgian FAGG. We are qualified and happy to help you.
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Ready to validate your cleaning processes?

Ensure your cleaning validation meets the highest standards of safety and compliance. Partner with QbD Group for a reliable, efficient, and stress-free approach to cleaning validation. Contact us today to discuss your project and discover how we can help.

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