Medical Devices
Catheter preparation extraction step
Particulate Matter Sample Prep
Cytotoxic, Lyophilized and Cancer drugs
These Hazardous materials are handled routinely by our staff. Experience in preparation and handling these materials can be difficult without contributing contamination. Our Class II Group B BioSafety cabinet ensures protection for our staff and the environment and provides a particulate free for preparation.
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.
