Cleaning Validation & Verification Services
Prevent cross-contamination and maintain regulatory compliance with comprehensive cleaning validation for your pharmaceutical manufacturing processes. Our validation services help you develop effective cleaning methods, establish acceptable residue limits, and document cleaning efficacy – while keeping costs manageable. Partner with us to protect product quality and streamline your validation process.
What are Pharmaceutical Cleaning Validation & Verification Services at Element?
Cleaning validation demonstrates that manufacturing equipment cleaning processes effectively remove product residues and cleaning agents to predetermined safety levels. There are significant health and safety implications involved with reusing manufacturing lines for biopharmaceutical products. At Element, we provide complete validation services from sampling plan development through routine monitoring, helping pharmaceutical manufacturers maintain product safety and regulatory compliance.
What Can Element Offer You For Cleaning Validation & Verification Services?
Key tests offered
Key tests offered
We deliver thorough validation through rinse water sampling, surface swab testing, and coupon sampling methods. Our analytical capabilities include total organic carbon (TOC) analysis and pH conductivity measurements. Each sampling method is validated to provide accurate residue detection and support your cleaning process verification needs. While cleaning verification ensures the validated cleaning process has been executed, we analyze both visible residue limits and worst-case residue scenarios.
Products and materials we test
Products and materials we test
Our validation services analyze residues from APIs, cleaning agents, excipients, preservatives, and decomposition products across your manufacturing environment. We evaluate all product contact surfaces using multiple sampling methods to establish acceptable residue limits (ARLs). Our comprehensive testing covers batch sizes, dosage levels, and equipment surface areas to create complete validation profiles that meet regulatory requirements.
Methods and solutions offered
Methods and solutions offered
Cleaning validation
Our validation solutions begin with sampling plan development and cleaning detection method development. We support you through protocol writing, method validation, recovery studies, and routine monitoring. Each solution incorporates cleaner residue detection methods and process verification tailored to your manufacturing environment. Our approach establishes baselines for cleanliness while meeting FDA and ICH guidelines.
To validate cleaning methods for pharmaceutical manufacturing lines, our expert scientists and chemists first assess the manufacturing environment and cleaning procedures. This involves identifying the chemical components of cleaning agents, as well as excipients, active pharmaceutical ingredients (APIs), decomposition products, and preservatives in drug formulations.
Comprehensive cleaning validation services include:
- Sampling plan development (technique, determination of acceptable residue limit (ARL), method of detection, analytes of interest)
- Cleaning detection method development
- Cleaner residue detection method development
- Cleaning validation protocol writing
- Method validation and recovery studies
- Cleaning process verification
- Routine cleaning monitoring sample analysis
Cleaning verification
Element experts perform cleaning verification by measuring total organic carbon (TOC) and pH conductivity to ensure the cleaning process is effective. We collect samples using rinse, swab, and coupon methods.
Visit our Frequently Asked Questions section below to learn more about these methods.
Which labs offer this service
Which labs offer this service
Our team operates from Life Sciences hubs across the world, providing global access to our expert capabilities. Find your nearest Life Sciences hub on our Locations Page.
Validation expertise
Validation expertise
Our scientists provide consultative guidance throughout the validation process, from initial method development through routine monitoring. We help optimize cleaning processes while maintaining strict regulatory compliance, backed by nearly 200 years of testing experience. Our teams understand pharmaceutical manufacturing environments and develop solutions that work for your specific needs.
Standards we test to and products we test
- FDA Guide to Inspection of Bulk Pharmaceutical Chemicals
- FDA Biotechnology Inspection Guide
- ICH Q7
- Active pharmaceutical ingredients (APIs)
- Cleaning agents and residues
- Excipients
- Preservatives
- Decomposition products
- Manufacturing equipment surfaces
- Rinse water samples
- Surface swabs
- Test coupons
Your Challenges, Our Solutions
Simplified regulatory compliance
Cross-contamination prevention mastered
Cost-effective quality achieved
Documentation excellence delivered
Why Choose Element
Global expertise
Complete validation solution
Scientific leadership
Proven track record
Frequently asked questions
How can manufacturers and compounding pharmacies ensure contamination-free medicines?
Biopharmaceutical manufacturers and compounding pharmacies can ensure contamination-free medicines by documenting their cleaning methods and demonstrating reliable control of API, material, and cleaning agent carryover.
How are samples collected for cleaning verification?
Cleaning verification measures total organic carbon (TOC) and pH conductivity. Samples are collected using three methods:
- Rinse method: Analysts collect a water sample from the final rinse, which recirculates over all surfaces, to identify chemical substances.
- Swab method: A wipe or swab moistened with purified water collects chemical residues from a defined area.
- Coupon method: Sample coupons are dipped in high-purity water to extract residues.
What are ARLs and how are they determined?
In the pharmaceutical and biopharmaceutical industries, an Acceptable Residue Limit (ARL) defines the maximum allowable residue on a product to prevent contamination of subsequent batches. ARLs ensure consumer safety and maintain the efficacy and accuracy of products manufactured on the same line. To establish an ARL, the residue levels on product contact surfaces of manufacturing equipment must be measured. These measurements only need to be repeated if there is a documented change in equipment or practices. When determining residue limits, Element’s scientists consider:
- Dosage levels: Pre-determined during R&D, helping define safe ratios of active ingredients (APIs), excipients, and residues.
- Batch sizes: Also set during R&D, influencing the ingredient-to-residue ratio for scaling.
- Equipment surface areas: Since vendors usually do not provide surface area details, understanding these areas helps assess exposure during manufacturing.
Why are ARLs important in biopharmaceutical cleaning validation?
Cleaning validation studies that encompass all levels of validation provide a comprehensive understanding of the cleaning process, eliminating the need to reconcile separate data points. An established Acceptable Residue Limit (ARL) forms the foundation of a robust cleaning validation that complies with FDA and ICH guidelines. It sets cleanliness baselines and works alongside:
- Visible Residue Limits (VRLs): VRLs define the threshold at which residues are no longer visible after cleaning. Viewing conditions are established to allow routine checks on cleaning procedures.
- Worst-case residues: A worst-case matrix identifies the residues hardest to clean, which pose the most significant risks if not removed properly.
- Recovery factors: Manufacturers must prove that cleaned equipment undergoes testing with swabs and rinses that accurately reflect its cleanliness.
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