Micro Measurement Laboratories

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Home Particulate Matter Testing Particle Identification Group Standards for Visual Inspection Particle Size Analysis Method Validation QA & Customer Service Contact

ACCURATE. EXPERT. STATE OF THE ART

One Inspection Stage For Specific Defect.

Standards for Visual Inspection

Quality Challenge Sets built on a solid reputation from over 30,000 standard containers over all
types over 11 years
Exceptionally clean containers - guaranteed no particle 25m
Exact (NIST traceable) sized particles, including all (custom made) non-spherical particles
Guaranteed up to 3 years
Expert technical support to determine the best mix of sizes for your requirements
Our experts can provide custom particles to match most any defects we can Identify in your rejects
Physical container defect duplication
Placebo formulations with identical appearance to cytotoxic products.
MML can provide a variety of
particle standards in your
containers for human and
automated inspection machine
qualification and/or validation of
specific performance. Our
standard sets are based on years
of experience working with Visual
Inspection groups at the largest
pharmaceutical companies.

Manual inspection system to simulate user techniques for

inspection.

Your product package is cleaned in our proprietary process that allows us to guarantee there is not a
single particle 25 microns. Thats 600 times cleaner than current USP <788> particulate matter limits
on your production containers. Each particle is sized with NIST traceability
Precise filling to meet process requirements.

Whether your product is packaged in a vial, syringe, ampule, IV bag or multi-compartment container,
we can provide the same level of cleanliness needed to ensure that the single particle (or blank) can be
classified as a standard, with NIST traceability for the particle size. Data you collect on inspector or
automated system qualification is enhanced because there is little or no affect from background
contamination.
For human inspector qualification, 3 different levels are available in our Standard Set.
Additional services are offered for certain containers to enhance the in use performance of our
standards, such as invisible closure of the needle passage for syringes/cartridges to prevent loss.

Some of the many particle types offered are :

SPHERES: glass, polystyrene, stainless steel, resin, polymer
FIBERS: silk, nylon, polyester, polypropylene, rayon (black or
white). Lengths similar to those in rejects.
FLOATERS:
CHARDS:

We offer the Standard Sets for most any container (syringe, vial, ampule, IV bag, etc.), filled with
WFI, or some drug products. Vials or ampoules are
optimized for automated inspection machine
qualification. Containers with physical defects such
as defined cracks, pin-holes, scratches and other
defects are also available. Special particles include
brass, stainless, copper, glass, a variety of fibers in
various lengths. All particles are sized traceable to
NIST.

For new production lines, we can usually duplicate your current

limited rejects, once we determine the nature of the particle.
For more information on our services, download the application
request form.
PHYSICAL DEFECTS
Many of the defects described in the recent industry report can
be provided for most container types.

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CUSTOMER SERVICE PAGE >>

FREE ADVICE and information for your needs on your

product
Expert advice for comparing Visible Inspection results with Sub-Visible data

Inspector Training for Visual Inspection

Consulting services for the use of Visual Inspection Standards
Industry published papers on a variety of topics on Visual Inspection methods
SEE THE PAGE ON PARTICLE IDENTIFICATION
TO GET MORE INFORMATION, CONTACT US

2009 Micro Measuerment Laboratories, Inc. All rights reserved.

01/20/2015 12:25 .

Micro Measurement Laboratories

2 of 2

http://www.mmlabs.com/visual_inspection.html

01/20/2015 12:25 .