Contract Testing for Particles - Identification of the Particle Source and Silicone Layer Investigation

By choosing rap.ID’s laboratory services, you gain access to years of experience as well as ISO 9001:2000 documented quality in the development of methods and routine analyses for the isolation, detection and identification of disruptive particle contamination.

Your Products:

Our Methods:

Syringes and Carpules

Microscopic Particle Counting

Parts and Components

Light Obscuration Particle Counting

Silicone Oil Layer Measurement

Parts Cleanliness Testing

Our laboratories use particle image analysis and Raman identification, combined with other procedures, such as EDX and IR spectroscopy, and customized for foreign particle analysis. We specifically select extension modules and additional methods to detect contamination in production processes for our valued customers worldwide.
rap.ID provides you with information about the number, size and chemical composition of the particles. The statistically significant particle identification allows you to find and quickly eliminate contamination sources.

Examples of Applications:

Identification of Particulate Matter - Reject Small Volume Parenteral

Foreign Particles in Dry Powder Inhalers

Troubleshooting in Clean Production Processes

Fast Chemical Mapping of a Dry Powder Inhaler Formulation

Local Silicone Layer Distribution in a Prefilled Syringe

Product Fact Sheets:

Particle Sources in Respiratory Drugs

Particle Sources in Parenterals

Contact Us:

Request Information

Should you exceed the particle specification bounds despite our efforts, we can track down the foreign particles in your product within hours, helping you maintain your competitive edge and allowing you to focus on your core competencies, particularly batch production of your high-quality products.

This gives you the chance to identify both the source of particle contamination as well as all the useful spectroscopic methods at the micrometer level. We are also willing to work together with you on investigating foreign particles in your products, such as specific methods for routine foreign particle assays and characterization. We are also capable of validating the methods according to the rigorous standards set by the pharmaceutical industry. If you would like to conduct routine analyses yourself in the future, we are happy to furnish you with the instructions and competent particle analysis devices tailored to your lab needs.

How to use rap.ID’s particle analysis services:

You send us the product to be analyzed.
We contact you about the scope of the analysis and then develop a measurement method.

Within a very short time, you receive the results of the analysis along with a clear and concise protocol, microscope images of the particles and a final report drafted by our staff experts.

Of course, we are also able to identify prepared microparticles already on the filters.

Our Services:

We use our patented filtr.AID particle isolation and identification technology to detect single particles and pinpoint their exact source of contamination on the basis of their respective chemical structure. The filtr.AID technology enables us to isolate particles from a vast range of different products through vacuum filtration on the filtr.AID membrane. The Particle Finder then automatically analyzes the filter membrane according to predetermined specifications and determines the particle size distribution.
The cleaning quality of the used materials and solvents is documented in a blind test. Our Particle Explorers use automated Raman spectroscopy for the reliable determination of the size, shape and chemical composition of particles 500 nm and larger.

Isolating Particles:

With the filtr.AID membrane, we can isolate particles from any given medium. As methods are developed, we adjust the size of the nuclear pores and effective filtration surface to the given measuring task. Documented blind samples are the first step toward ensuring a clean workplace, media and equipment.

Particle Recognition:

The fully-automated image analysis allows the evaluation of the entire particle-laden area of a sample and the determination of particle size distribution. Shape parameters, such as roundness and rectangularity, are additionally evaluated.

Size class	> 10 µm	>25 µm	>50 µm	>100 µm
Count	1850	173	52	1

Particle Identification:

The Particle Explorer automatically selects the particle on the basis of certain predetermined criteria and positions it into a laser focus of approx. 2 µm. Manual selection of irregular individual particles found during optical inspection is also possible. Although integration time and other parameters are usually selected automatically, they can be adjusted manually as well.
The integrated spectrum analysis removes the fluorescent background, and the database search automatically analyzes the position and area below the peaks, finding the best match from the substance database.
The rap.ID database contains nearly all the materials that are relevant in cleanroom production, including lubricants, rubber tubes and seals, clothing, human dust, organic and inorganic filling materials, rubber stoppers, packing materials as well as cleaning agents and cloths. Your specific auxiliary and active substances can be easily and reliably integrated into your customer database.

Method Development & Validation:

We assist you in the preparation of foreign particle studies for pharmaceutical development, from method development to routine testing for foreign particles. Method validation uses performance parameters which are decisive for the value of the analysis, such as linearity, robustness, reproducibility, and precision. We draw our method validation experience from several successful validation studies, particularly in the foreign particle analysis of modern dry powder inhalers and nasal spray products.

Documentation & Compliance:

Quality management compliant to the internationally recognized ISO 9001:2000 standards is the key requirement for the production of our particle analysis equipment as well as for our analyses. The measuring instruments in our laboratory must also pass the qualification process and are only used upon successful performance verification. They are also subject to continuous measuring instrument controls.

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