Newsletter Parenterals

Foreign Particles in Parenterals:

Although considerable effort is devoted to ensuring cleanliness – i.e., the absence of visible particles – in the production and control of parenterals, as much as 0.1% to 3% of all batches produced are wasted and discarded as rejects due to contamination which, in turn, results in lower yields. Manufacturers failing to meet the functional specifications sometimes have to block or possibly even destroy entire batches. Returns, products rejected by the end customer, cause even greater damage. The Single Particle Explorer rapidly provides you with the relevant information required forthe detection, enumeration, and identification of foreign particles, in turn, facilitating timely and objective decisions regarding contamination sources.

Integrated Sampling, Fast Counting:

The Single Particle Explorer was designed specifically for the routine counting and identification of foreign particles in parenterals. Its integrated sampling solution, which eliminates the risk of cross-contamination, makes vacuum filtration of the parenterals under examination a matter of minutes and saves the user invaluable analysis time. All particles on the membrane larger than 10µm are counted and documented within just 1 minute, in strict compliance with international pharmacopoeia. Although as simple as a particle counter, this tool provides far more detailed information thanks to the particle size and shape analysis.

Standardized Reject Analysis:

The SPE uses highly sensitive vibrational spectroscopic methods to identify particulate contamination sources. Any user can learn how to determine a particle's chemical compositions based on individual Raman fingerprints after only one day of training.The particles are detected and subsequently identified using the integrated database. Corrective and Preventive Action (CAPA), which is mandatory when dealing with customers in the USA and Japan, can easily be integrated into the standard quality control system.

Trend Analyses Become Affordable:

Fully automated foreign particle characterization provides statistical sample analysis. Trend Analyses, which would normally take several months using traditional methods, can now be performed in a matter of hours requiring minimal human and technological resources. Valuable stability information accelerates the development of sensitive biopharmaceuticals. Quality improvements in parenteral production and filling help ensure larger production volumes as well as maximum customer satisfaction.

Qualified Measurement System:

The SPE is manufactured according to ISO 9001:2008 standards for optimal use in a cGMP environment. All data is stored in compliance with CFR Part 11. Customizable IQ/OQ/PQ documentation can be quickly integrated into your documentation environment. In addition, rap.ID will gladly assist you in your method development and validation efforts, should you so require.