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
Micro Measurement Laboratories, Inc. provides contract testing for comendial 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, Diagnostic reagent preparations
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 5 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 definitely a concern in today’s parenterals and have been found in unexpected sources, such as filling operations. Current methods in USP<788> are not adequate to measure these sub-visible particles.
MML has acquired a unique MFI state of the art instrument to measure proteins and already participated in a recent study soon be published. The study measured some common proteins using USP788 methods as well as MFI,to provide a useful insight into the measurement of these particles. References on these topics are available on request. One instrument utilized for this work is the Brightwell DPA4100,which integrates the capabilities of digital microcroscopy, micro-fluidics and image processing on acquired images which are then analyzed to show counts, size, shape and intensity.
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.
