Particle Validation Standards
Certified and Customized Sets for Visual Inspection Training Programs
Visible particulates in injectable products can jeopardize patient safety. Therefore, reliable control of particulate contamination in fill and finish process steps is essential. Control measures include visual inspection of the final drug product to ensure it is "essentially free" or "practically free" of particles.
Our Particle Validation Standards comprise a broad range of custom-manufactured standards designed to validate the visual inspection process.
Each kit is specially designed and supplied with a certificate of compliance & traceability.
Fabrication, processing, and inspection are performed under ISO 9001 QMS.
Reliability secured by over 40 years’ experience and global coverage from our site in North America.
Custom-Designed Kits to Fit Your Unique Requirements
Packaging
A Range of Packaging Options
Standards are fabricated using customer-supplied containers and seals to ensure consistency. We support numerous packaging types:
- Ampoules (Glass, up to 128 mm height)
- Syringes (Glass, non-graduated)
- Vials (Glass, up to 100 mL)
- Cartridges (Glass, non-graduated)
- CZ Vials | Syringes
- Cryotubes
Fill Solutions
Fill Solutions Supporting a Range of Applications
We offer three types of fill solutions:
- Bacteriostatic water
- HPLC high-purity water or WFI
- Customer-supplied fill solutions, i.e, drug product, placebo, or custom solutions (subject to review and pre-approval of the SDS).
Colorization available for standard and custom solutions (upon testing).
Standard and Customized Options
Visual inspection training kits are designed to replicate potential extrinsic, intrinsic, and inherent sources of product or process contamination.
We offer a range of standard and customized particle covering glass spheres | shards, polystyrene spheres, stainless steel shards, hair, fibers, rubber | plastic defects, and cosmetic defects (see table below). There are additional packaging options and associated cosmetic defects for glassware.
Particle | Size Range (μm) | Available Sizes (μm) |
|---|---|---|
| Clear Glass Spheres | 100 – 2000 | 100 - 600 (inclusive), 650, 750, 950 and 2000 |
| Black Glass Spheres | 100 - 1130 | Inclusive |
| Clear Polystyrene Spheres | 100 - 1000 | 100 - 500 (inclusive), 750 and 1000 |
| Black Polystyrene Spheres | 100 – 500 | Inclusive |
| Red Polystyrene Spheres | 100-500 | Request availability |
| Glass Shards | 100+ | Amber or clear |
| Fibers, any color (including clear or fluorescent) | 500+ | Recommended to start at 500 μm |
| Stainless steel shards | 100 + | 100 - 1500 |
| Rubber from stoppers/plungers | 100+ | 100+ |
| Gross underfill/overfill | N/A | Volume specified by customer |
| Variances in plunger height (syringes) | N/A | Height specified by customer |
| Cracks in glassware | N/A | Inquire about options |
| Blanks | N/A | N/A |
| Hair (light, dark or mixed) | 500 + | 500 + |
| Cosmetic defects | N/A | Glassware/fill solution/sealing /stopper |
Fully Personalized Solutions
Each standard set is created according to customer specification, based on:
- Packaging type and size
- Fill solution | fill volume
- Particle material types | colors | sizes
- Particle quantity per container
- Container quantity per particle type | size
- Packaging cosmetic defects
- Label specifications
Quality (Process & Certification)
Improved Confidence
Fabrication of kits follow proprietary in-house processes following current ISO standards.
- Skilled lab technicians highly experienced in validation standards production processes
- Projects fabricated in dedicated labs with HEPA-filtered laminar flow hoods
Certificate of compliance & National Institute of Standards and Technology (NIST) traceability supplied with each kit.
- Particle tolerance range
- Particle lot traceability
- Fill volume tolerance
Flexible Solutions for Unique Products
Loose Particles for Lyophilized Products
We offer NIST traceable particles allowing you to seed products at your own site and avoid potential degradation and loss associated with lyophilization.
High Viscosity Solutions
We accept emulsions, meaning no filtration is required at filling steps during fabrication.
Non-Standard Packaging Options
We can work with a variety of non-standard packaging (subject to evaluation), creating a bespoke service.
Bespoke Solutions to Meet Your Visual Inspection Requirements
Frequently Asked Questions - Particle Validation Standards
Particulates are mobile, undissolved particles (other than gas bubbles) that are inadvertently introduced to an injectable product.
Visible particulates in injectable products can cause an undesirable physiological response, representing a patient safety risk.
Ideally, automatic visual inspection (AVI) machines and human inspectors should be tested using separate particle validation standards for each potential type of contaminant in the manufacturing process.
No regulation currently addresses this. The process is considered valid as long as the inspection system can consistently detect the smallest recognized (i.e., threshold) particle. A consistent detection rate of about 80% is a key specification for both human and automated inspection systems.
After investigating potential sources of material contamination, particle validation standards that fairly represent those possible contaminants should be selected. As an example, the following guidelines represent standard contaminants by container type:
- Ampoules – glass and fiber
- Vials - glass, fiber, rubber stopper, and aluminum
- Syringes – glass, fiber, plunger material, and stainless steel
Additionally, potential contaminants or conditions unique to each process, such as overfilled and underfilled standards, plunger position standards, cosmetic defects, and blanks, may be included.
Custom particles are an option if stock materials do not replicate a particle contaminant. Customers may submit their material to our technical team for evaluation.
It is highly recommended to have a set of standards made for each type of glassware as particles will act differently depending on the shape and size of the container and fill volumes. Packaging types such as amber glassware adds a level of difficulty to the detection process.
No, Customers are required to supply packaging as used in their current manufacturing process (or aligned against their visual inspection training needs). They must be provided in the same quality and cleanliness conditions. To achieve this, you should collect your containers after the washing procedure but before filling. If this is not possible or practical, unopened containers from your glass supplier may be provided.
Bacteriostatic water is the traditional fluid fill except when the usual product fill is significantly different in viscosity or turbidity.
In these cases, particle validation standards may be created with the customer product (a safety data sheet is required prior to quoting).
Rubber stoppers or plungers should have some type of coating on them to keep particles from sticking to them (like Teflon®; OmniFlex® or FluroTec® barrier film stoppers).
Rubber stoppers or plungers with a non-stick coating enhance the free flow of particles in solution. Particles may adhere to uncoated rubber stoppers, rendering the standard unreliable. Stoppers with elaborate 3D structures, such as those used for lyophilized products, may also trap particles.
