Micro Measurement Laboratories
- North America
- United States
- Service category
- Contract manufacturing, filling and packaging, Pharmaceutical process development and validation, …
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- Analytical service / development / validation
- Parenteralia / injectables
- Particle testing service
- Quality assurance
- Training / coaching
Particulate Matter Testing
Compendial methods – USP, EMEA, JP as well as ISO, ASTM, EN, etc.
Parenteral products of all sizes/types, TPN’s/TPA, injectable emulsions, ophthalmics, highly viscous or opaque solutions, etc.
Medical devices, implantable, surgical, device sets/parts, transdermal, etc.
Nanometer, Sub-micron applications
Micro Measurement Laboratories, Inc. provides contract testing for compendial particulate matter requirements as well as research investigation work on most any pharmaceutical product. We also provide particle size distribution analysis for pharmaceutical (API, excipient, etc.) and food ingredients, flavorings, etc.
PHARMACEUTICAL INJECTABLE PARENTERALS
Liquid formulations including proteins, oligo’s, lyophilized products, as well as many others.
From routine preparation and testing, to many problems can be associated with
MML offers a wide variety of particulate matter testing services for almost any parenteral and has developed hundreds of methods and techniques to investigate many formulation and package related issues. We offer several different laser instrumental based approved systems with a variety of advantages for different product types, and several microscopic membrane methods.
Protein Particles can be visible or sub-visible in parenterals and can result from proteins alone or from nucleation with other sources. Sub-visible proteins (especially ≤ 10µm) are a concern in today’s parenterals and be expectedly formed by anomalies in the filling process and/or from package components. Current methods in USP<788> are not adequate to measure these sub-visible particles.
MML has acquired new state of the art particle size and counting instruments to measure particles ≤ 10 µm. Two Dynamic Fluid Imaging (DFI)”, systems are available to measure protein solutions ≥ 1 µm, which provide size, shape as well as intensity information about each particle, and can compare droplets of different materials. Another state of the art instrument has been added to size and count particles as small as 50 nanometers, and a third, which new system can measure larger volumes (≥ 5 mL’s) of sample for particles ≥ 150 nm, up to 400 µm. This size range represents not only the large (aggregated stages of proteins, but provides information on the early/initial stages of protein aggregation. References on these topics are available on request.
Particulate Matter Testing of Elastomeric Closures, plungers, barrels, vials, components…
MML provides complete particulate testing and investigations for a wide variety of elastomeric closure applications, including particulate matter, sterilization residuals, and product interactions.
Compendial tests are performed to determine if the material's specifications are met and/or to address anticipated regulatory concerns. These test series can also be applied to determine general drug compatibility or for routine quality control. Some applicable standards :(USP) <381>; EP 3.2.9; JP, Sec. 59; ISO 8871
(USP) <381> ; EP (Ph. Eur.) 3.2.9, require specific test methods to ensure compliance. Powders, and for Freeze Dried Powders," Pharmacopoeia of Japan (JP), Section 59; ISO 8871 and others.
Particle Identification Group
Microanalysis also has applications for problem solving in many industries. This includes general contamination, powders, fibers (natural and synthetic, hair, paper, wood), polymer and materials identification, (multi-laminate films, coatings, metals, minerals, corrosion analysis, consumer complaints, competitor monitoring, etc.)
To support these problems, analytical techniques and instruments are utilized using microscopes and microscope-based instrumentation. These include:
Filtration or manual isolation in a HEPA filtered area onto an appropriate filter/media for subsequent analysis, including special coated/treated membranes.
Stereomicroscopy (general observation and sample preparation).
Polarized Light Microscopy (morphology, fibers, crystallinity, birefringence).
Using transmission, reflectance, and ATR techniques, infrared analysis can be applied to macro-sized samples as well as to individual particles as small as 20um. This technique is most valuable for organic compounds. Gives information about the covalent bonds and functional groups present in compounds, allowing class or specific identification.
Scanning Electron Microscopy with Energy Dispersive Spectroscopy. SEM provides imaging and EDS provides elemental information about the sample. Best for metals, minerals, metal salts of organic compounds, and metal-containing organic compounds.
Imaging and documentation.
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.
Particle Size Analysis
Some of the state of the Art Instrumentation for particle size analysis
AccuSizer 780 a fully automated, high resolution particle sizing instrument that uses the principle of light obscuration to count and size particles one at a time from 0.5 - 2500 microns. The 780 provides the true particle size distribution, clearly showing the details of the distribution that other ‘Ensemble’ technologies usually miss. A variety of materials behave differently in use when certain portions of the overall size distribution are changed only slightly. The Accusizer system offers a unique means not available on other ‘ensemble methods’ to quickly characterize fines and aggregates, as well as very subtle changes in the shape of the main distribution. These results are often tell tale signs of process problems.
Size distribution testing...
- Protein aggregation
- Food ingredients
- Sieving – dry
- Laser diffraction
- Dynamic Light Scattering
- Single Particle Optical Sensing
- Light Obscuration
- Image Analysis including (MFI) Micro Fluid Imaging
MML can provide extensive expertise in the following areas :
METHOD DEVELOPMENT for:
- particle testing or visual inspection
- Instrumental testing
- Process pass/fail determination criteria
- Scale up
- Nearly all aspects of Visual Inspection –vs- Sub-visible
COMPENDIAL METHOD VALIDATION
- Complete Risk Analysis
- Laboratory Test Methods
- Instrumental DQ/IQ/OQ/PQ/MQ
- Coordination of supplier and customer specifications
METHOD INVESTIGATIONS for test results in OOT, OOS, Statistical Analysis
QA & Customer Service
Every aspect of our operations is monitored by QA through regular internal audits, training and document review.
MML has been providing Training for over 15 yrs to large Pharm-Med-BioTech companies in areas of :
- Test Methods, Protocols, Method Transfers
- Compendial protocols such as USP/EP/JP/ASTM/ISO methods
- Instrument startup and operation
- Instrument Performance Qualification or Maintenance
- Instrument Calibration
Approvals, Certificates, Authorisations
- ISO 8871
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