Particle Validation Standards
As international demand for pharmaceutical product quality increases, so does the need for reliable, efficient control of particulate contamination.The unintentional presence of extraneous, mobile and undissolved particles in a parenteral solution must be detected and remediated as part of any robust quality program.Pharmaceutical processes can include several sources of potential particulate contamination:shards from chipped glassware, fibers from clean room cloths, stainless steel shavings from the production area, and many more.Detection of these contaminants through manual or automated methods is necessary to ensure affected units never reach the clinic.颇尔 SoloHill Particle Validation Standards support the training and testing of human inspectors and are designed to challenge and validate both manual and automated visual inspection methods.
Key Features and Benefits
- Manufactured under a robust ISO certified quality program
- Flexible options simulate a wide variety of potential contaminats
- Customized standards reflect the risks of your production environment
Utilizing our unique Project Matrix, projects are designed based on exact requirements for container type and closure, fill solution and volume, as well as particulate type, size and number.
All particle validation standard kits are assembled by experienced lab technicians trained in aseptic handling using HEPA-filtered laminar flow hoods, Standards are fabricated utilizing customer supplied containers and seals, thus minimizing potential variations due to glassware manufacturers.
The SoloHill Particle Validation Quality System is certified to rigorous ISO 9001:2008 and ISO 13485:2003 standards.
All projects are completed using the following
- Skilled lab technicians highly experienced in validation standards production processes, including drug product handling.
- Projects fabricated in dedicated labs with HEPA-filtered laminar flow hoods
- Semi-automatic inspection stations with Tyndall lighting
- Precise particle sizing traceable to the National Institute of Standards and Technology (NIST)
- Certificate of Compliance & Traceability provided for all projects
- Additional documentation, including a Certificate of Measure for individual particles, is available upon request
SoloHill Particle Validation Standard technical support specialists can assist you in identifying the optimal validation standards for your needs.
Custom Defect Kits may contain any of the particle types below.
|Particle||Size Range (μm)||Available Sizes (μm)|
|Glass Spheres||50 – 2000||50 – 590 (inclusive) 650, 750, 950, 1000, and 2000|
|Black Glass/Basalt Spheres||50 – 2400||50 – 2400 (inclusive)|
Plastic Spheres, Clear or Opaque
polystyrene or polyethylene
|50 – 500||50, 60, 70, 80, 100, 115, 140, 160, 200, 240, 280, 300, 400, 500, 550, 650, 750, and 1000|
|Black Polystyrene Spheres||50 – 500||50, 100, 150, 200, 300, 400 and 500|
|Red Polystyrene Spheres||by request||request availability|
|Green Fluorescent Spheres||by request||request availability|
colored, clear or fluorescent
light, dark or a mix of both
|Stainless Steel Shards||50+||unlimited|
stock material may be submitted
|50+||size availability dependent on material inspection and acceptance|
|Underfilled/Overfilled Containers||as needed||不可用|
|Cracks in Glassware||as needed||不可用|
Total Quality System certified to ISO 9001:2008 and ISO 13485:2003 standards
Particle Validation Standards are available in a number of custom configurations For more information, Contact Us
Ideally, automatic inspection machines and human inspectors should be tested using separate Particle Validation Standards for each potential type of contaminant in the manufacturing process.
After investigating potential sources of material contamination, Particle Validation Standards may be selected which fairly represent those possible contaminants.As an example, the following guidelines represent standard contaminants by container type:
- Ampoules – Glass & Fiber
- Vials - Glass, Fiber, Rubber Stopper & Aluminum
- Syringes – Glass, Fiber, Plunger Material & Stainless Steel
Additionally, potential contaminants or conditions unique to each process may be included, such as overfilled and underfilled standards, plunger position standards, and blanks.Our technical support team can assist you in determining the best mix of particles for your needs.
Due to material properties, Tyvek fibers cannot be accurately characterized for inclusion in Particle Validation Standards.Tyvek custom particles are not available at this time.
Automated inspection machines should be tested with each glassware type.Particle behaviour varies based on container configurations.
Yes - Supplied containers must be provided in the same quality and cleanliness conditions as the containers used in your current manufacturing.To achieve this, containers should be collected after the washing procedure, but before filling.If that is not possible or practical, unopened containers from your glass supplier may be provided.
Rubber stoppers with a non-stick coating are recommended to 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.
Typically blank or single particle standards are fabricated.Upon request, two or three particles per container can be added to your order.Requests for more than 3 particles will be handled on a case-by-case basis.
Our qualified technicians are able to insert particles as small as 50 microns for use in automated inspection machine validation.
Particle Validation Standards less than 100 microns may adhere to rubber stoppers or wedge between stoppers/plungers and the glass of the container.
The minimum size requested for validation of human inspectors is typically 100-200µm depending on the particle type.
Automated inspection machines are usually equipped with black and white cameras and human inspectors cannot detect color differences in small particles.As such, particle color may not be critical for your process.However, your particle validation standards should be representative of contaminants that are clear and opaque, reflective and non-reflective, light and heavy in weight, bright and dark in color and of different shapes.
Any solid particle can be used to create particle validation standards for a lyophilized product.
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 your product (A Safety Data Sheet is required prior to quoting).
It is very rare to have any reaction between the particle and the standard bacteriostatic fill solution.
A Certificate of Compliance and Traceability is included with each order at no extra charge.This Certificate states that particle sizing is conducted with measuring instruments traceable to the National Institute of Standards and Technology (NIST) and that the standards are made in accordance with ISO 9001:2008 and 13485:2003 Quality System guidelines.
There is a minimum order of at least 20 units. if ordering less than five (5) validation standards per particle type/size, a set-up fee will be included in the quote.
Most containers are provided unmarked and a key is provided in your partitioned validation standards kit which identifies particle size, type, etc., by compartment.
Any other labeling considerations may be specified by the customer during their initial inquiry.
Smaller projects may be individually marked with a unique number using a written label or ultraviolet marker.Bar-coded labels provided by the customer will be considered upon request.
The certificate for each lot typically has a two-year expiration date.Depending on fill solution and particle type the expiration may vary.
All drug products and syringes are returned to the Customer.Extra glassware and other supplies are disposed of or recycled, unless prior arrangements are made.Returned items will incur a separate handling fee and standard shipping charges.
Partial shipments can be made but will incur a separate handling fee to cover the administrative costs of multiple shipments.Standard shipping costs will also apply to each shipment.
This will depend on the project specifics such as quantity ordered, particle sizes, and resource availability.Lead times are custom-quoted for each project.
Automated visual systems should be validated using the recommendations of the machine manufacturer or after any adjustments or modifications have been made to the system.
A false positive reading is possible in cases such as bubbles in the fluid, irregular light beams that cause reflections, if the bottom of the product container is irregularly shaped or if an automated visual inspection system is set for high sensitivity.
Custom Defect Kits
Particle Validation Standard quotes are based on customized defect kit design.
- Fill media
- Fill volume
- Particle material
- Particle quantity