Layer Explorer with Siliconization Control an International Success
New Technology from rap.ID Particle Systems Quickly Established in the
Pharmaceutical Industry

Berlin, 30. September 2008: Rap.ID Particle Systems’ Layer Explorer sets new
standards in measurement technology. For the first time, manufacturers and
fillers of products for the pharmaceutical industry are able to determine
with nanometer precision the distribution and thickness of silicon layers in
parenteral primary packaging, such as syringes, cartridges, carpules, and
vials, without destroying or even interfering with the syringe or the
silicon layer. The dynamically growing market has been unusually quick in
integrating the new technology of Layer Explorer.
Only one year after Layer Explorer was first presented in New York, one of
the leading manufacturers of biopharmaceutical products in the US is now
using this analysis instrument. Also, the world’s largest manufacturers of
prefilled syringes relies on Layer Explorer for the quick optical
characterization of silicone oil layers, even in the development of its
innovative pharmaceutical packaging.
Prefilled syringes are modern yet complex application systems which have
been playing an increasingly important role in the fields of pharmaceuticals
and biotechnology. Knowing the siliconization profile of each individual
nozzle in a production line allows manufacturers and users to quickly and
accurately determine and apply better parameters. The quality and chemical
characteristics of the analyzed packaging are documented for the customer in
a reproducible and comparable manner.
A leading vaccine manufacturer also uses Layer Explorer to measure the
homogeneity and amount of silicone oil prior to filling its valuable
vaccines, in order to prevent syringe plungers from sticking during
vaccination. This helps to prevent the malfunctioning of individual syringes
or even recalling entire batches. Layer Explorer allows manufacturers of
monoclonal antibody solutions, for example, to analyze the silicone layer
even after filling without wasting any of their valuable products.
The technology also benefits plant manufacturers. A leading equipment
supplier for pharmaceutical filling lines uses Layer Explorer to optimize
the parameters for the siliconization stations of its manufacturing machines
and to quickly achieve high-quality and measurable siliconization results.
As well as providing a measurable advantage in know-how, Layer Explorer also
helps to save costs. Considering an estimated price of €800 per syringe, the
low investment costs for the highly-automated measuring system will pay off
quickly. Dr. Oliver Valet, Managing Director of rap.ID Particle Systems,
states that „The analysis of a syringe can be completed within one minute
with minimal human resources. If the system prevents the loss of only 50
expensive syringes, it has already paid for itself.“
Enterprises with no integrated analysis systems of their own can use rap.ID’
s analysis service. There are now more than 20 companies in Europe, the USA,
and India which send syringes and cartridges on a regular basis, benefiting
from the results obtained at the rap.ID Berlin laboratories.
Rap.ID Particle Systems offers unique measuring systems and services. All
applications are developed according to the requirements of the
pharmaceutical industry and in compliance with ISO 9001:2000 and GAMP IV,
and are delivered complete with IQ, OQ, and PQ validation documentation. All
measurement results are generated and stored in accordance with 21 CFR PART
11.
For further information, please visit www.siliconization.com and
www.rap-ID.com.


rap.ID Particle Systems GmbH Phone: 030/ 6576 3440 Köpenicker Str. 325,
Haus 40c, 12555 Berlin E-mail: information@rap-ID.com