pall,颇尔,SoloHill 颗粒验证标准,

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SoloHill 颗粒验证标准
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pall,颇尔,SoloHill 颗粒验证标准,
pall,颇尔,SoloHill 颗粒验证标准

SoloHill 颗粒验证标准

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.

优质

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

技术支持

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
Glass Shards 50+ unlimited
Fibers
colored, clear or fluorescent
50+ unlimited
Hair
light, dark or a mix of both
50+ unlimited
Stainless Steel Shards 50+ unlimited
Aluminum Shards 50+ unlimited
Rubber Particles
from stoppers/plungers
50+ unlimited
Custom Particles
stock material may be submitted
50+ size availability dependent on material inspection and acceptance
Underfilled/Overfilled Containers as needed 不可用
Plunger Height
syringes/catridges
as needed 不可用
Cracks in Glassware as needed 不可用
Blanks 不可用 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

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

Custom Defect Kits

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

  • Container
  • Fill media
  • Fill volume
  • Particle material
  • 颗粒尺寸
  • Particle quantity

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