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SoloHill Particle Validation Standards

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. Pall 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 contaminants
  • 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 using HEPA-filtered laminar flow hoods, Standards are fabricated utilizing customer supplied containers and seals, thus minimizing potential variations due to glassware manufacturers.

Quality

The SoloHill Particle Validation Quality System is certified to rigorous ISO 9001:current version 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

Technical Support

SoloHill Particle Validation Standard technical support specialists can assist you in identifying the optimal validation standards for your needs.



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Description

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. Pall 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 contaminants
  • 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 using HEPA-filtered laminar flow hoods, Standards are fabricated utilizing customer supplied containers and seals, thus minimizing potential variations due to glassware manufacturers.

Quality

The SoloHill Particle Validation Quality System is certified to rigorous ISO 9001:current version 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

Technical Support

SoloHill Particle Validation Standard technical support specialists can assist you in identifying the optimal validation standards for your needs.

Specifications

Custom Defect Kits may contain any of the particle types below.

 
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
 

Total Quality System certified to ISO 9001

Particle Validation Standards are available in a number of custom configurations For more information, Contact Us

Additional Information
Click to expand/collapse this section When validating a visual inspection process, are individual particle validation standards needed for each potential contaminant?
Click to expand/collapse this section What are the criteria for determining the material type for particle validation standards?
Click to expand/collapse this section If a process includes glass vials, glass ampoules and glass syringes, are separate particle validation standards required for each container type?
Click to expand/collapse this section Can containers be supplied to create particle validation standards?
Click to expand/collapse this section What stoppers can be used for particle standard closure?
Click to expand/collapse this section How many particles can be inserted into each standard?
Click to expand/collapse this section What is the smallest available particle size?
Click to expand/collapse this section What are the criteria for determining the ideal particle color?
Click to expand/collapse this section Is bacteriostatic water the best fluid fill?
Click to expand/collapse this section Can fluid degrade or discolor the particle standard; can particle standards affect the fluid?
Click to expand/collapse this section Are Quality Certificates available for every order?
Click to expand/collapse this section Is there a minimum quantity per order?
Click to expand/collapse this section How are particle standards labeled?
Click to expand/collapse this section Is there an expiration date on the particle standard?
Click to expand/collapse this section How are remnants of customer supplied components handled after an order is fabricated?
Click to expand/collapse this section Can orders be received in partial shipments?
Click to expand/collapse this section What is the typical lead time?
Click to expand/collapse this section How often should automatic inspection machines be validated?
Click to expand/collapse this section What can cause a false positive?
Ordering Information

Custom Defect Kits

Particle Validation Standard quotes are based on customized defect kit design.

  • Container
  • Fill media
  • Fill volume
  • Particle material
  • Particle size
  • Particle quantity
Application
Standards
Segment
Filling Technologies