One Inspection Stage For Specific Defect.
Manual inspection system to simulate user techniques for inspection.
Precise filling to meet process requirements.
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:
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.
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 ≥ 25µm
- 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.
Your product package is cleaned in our proprietary process that allows us to guarantee there is not a single particle ≥ 25 microns. That’s 600 times cleaner than current USP <788> particulate matter limits on your production containers. Each particle is sized with NIST traceability
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.
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.
Using our special process, syringe paths can be sealed to prevent loss, and the method is absolutely not detectable during inspection by either humans or automated systems.
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
