Visual inspection is a critical aspect of ensuring the safety of injectable drug products. The presence of visible particulates can pose significant risks to patient safety. In response to this concern, our Particle Validation Standards offer certified and customized sets designed to validate the visual inspection process, ensuring that the final drug product is particles-free.
Certified Custom Defect Kits
Our Particle Validation Standards include Certified Custom Defect Kits, each meticulously designed and accompanied by a certificate of compliance and traceability. We prioritize quality and a customer-centric approach, offering custom-designed kits to fit unique requirements.
Certified Custom Defect Kits: Impeccably crafted, each kit has a certificate of compliance and traceability, ensuring precision and reliability in every use.
Quality: Our commitment to excellence is evident in our ISO 9001 Quality Management System, meticulously applied to every stage of fabrication, processing, and inspection.
Customer-Centric: With over 40 years of experience, we provide global coverage from our North American site, guaranteeing reliability and personalized service tailored to your unique needs.
Packaging Options
We provide a range of packaging options, utilizing customer-supplied containers and seals to maintain consistency. Our support extends to various packaging types, including ampoules, syringes, vials, cartridges, CZ vials, needles, and cryotubes. Please consult with our experts to find the best fit for your needs.
Fill Solutions
Our fill solutions cater to various applications, offering bacteriostatic water, HPLC high-purity water or WFI, and flexibility for customer-supplied fill solutions. Colourization is available for both standard and custom solutions upon testing.
Particle and Cosmetic Defects
Our visual inspection training kits replicate potential sources of contamination, covering extrinsic, intrinsic, and inherent defects. Standard and customized options include glass spheres, shards, polystyrene spheres, stainless steel shards, hair, fibres, rubber, plastic defects, and cosmetic defects.
Customized Design
We pride ourselves on fully personalized solutions. Each standard set is crafted based on customer specifications, considering packaging type and size, fill solution and volume, particle material types, colours, sizes, quantity per container, container quantity per particle type and size, packaging cosmetic defects, and label specifications.
Quality Assurance
Our fabrication process adheres to proprietary in-house processes following current ISO standards. Skilled lab technicians working in dedicated labs with HEPA-filtered laminar flow hoods ensure the highest quality. Each kit is accompanied by a certificate of compliance and National Institute of Standards and Technology (NIST) traceability.
Flexible Solutions for Unique Products
We understand that different products have unique requirements. Our offerings include:
- Loose particles for lyophilized products.
- High-viscosity solutions without the need for filtration.
- Accommodation of non-standard packaging options.
Precision in Particle Seeding for Lyophilized Products
Experience the freedom of seeding your products with NIST traceable particles at your site, avoiding degradation and losses linked with lyophilization.
Seamless Fabrication with High Viscosity Solutions
Embrace hassle-free fabrication – our acceptance of emulsions means no filtration headaches during the filling steps.
Bespoke Packaging Solutions Beyond the Norm
Unlock the potential of non-standard packaging with our evaluated bespoke services tailored to your unique needs.
Frequently Asked Questions – Particle Validation Standards
What is particulate matter?
Particulates are undissolved particles inadvertently introduced to an injectable product, excluding gas bubbles.
Why is particulate matter of concern?
Visible particulates can cause undesirable physiological responses, posing a risk to patient safety.
Are separate standards needed for each potential contaminant?
Ideally, separate standards for each potential contaminant are recommended for human and automated inspection systems.
What is the FDA’s perspective on PVS?
No specific regulation addresses this, but consistent detection of the smallest recognized particle is crucial.
Criteria for determining material types?
Materials should represent possible contaminants based on container types, and custom particles are an option if stock materials don’t replicate contaminants.
Separate standards for different container types?
Yes, it’s highly recommended to have standards for each type of glassware due to different container shapes and sizes.
Does Biotech Verde supply packaging?
No, customers must supply packaging used in their manufacturing process.
Is bacteriostatic water the best fluid fill?
It’s traditional, but adjustments may be needed based on the product’s viscosity or turbidity.
Can contamination originate from stoppers and plungers?
Proper coatings on rubber stoppers or plungers are essential to prevent particle adhesion.
Related Assets
Check out the SoloHill® Particle Validation Standards in this handy datasheet! It’s your go-to guide for all the essential information in a convenient PDF format – just a click away for a deeper dive into the details.
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Explore Final Filling: Delve into the world of single-use solutions and discover how our technology can revolutionize your final filling processes, ensuring the delivery of safe and uncontaminated pharmaceutical products.
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Experience confidence and efficiency in your process validation with Biotech Verde. Our comprehensive Validation Services combine analytical expertise, regulatory knowledge, and process know-how. Whether you are navigating the complexities of regulatory compliance or seeking to optimize your manufacturing processes, our team is dedicated to providing tailored solutions that meet the unique needs of your operation.
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