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Dear Customer
Krieger has proven over the years to be an excellent partner for Quality by Design projects. Our international engineering team develops and designs new types of processing equipment based on the knowledge of our customers, research findings and Kriegers processing excellence know how.
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Krieger provides technical solutions that find their way into specially designed turnkey equipment that meet current quality by design standards and that guarantee our customers required product quality.
This newsletter gives insight how Krieger can be of assistance in building quality by design into your projects.
Yours Faithfully,
Guy Akkermans
CEO
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| Krieger has a long reputation of Designing Special Equipment |
| Krieger designs installations tailored to our customers' specifications. In a first phase - the design qualification - the client specifies all process and user requirements and combined with Krieger's concept proposals a final design is worked out.
Krieger then installs the equipment built according to the criteria established in the design qualification on site and performs IQ/OQ testing. In a next step our validation engineers perform a PQ, which is the final phase before the launch of the first validated production batch.
Some Special Projects
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Roche:
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HIV Coating installation
MMT 300
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1994
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Novartis:
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Kleisteranlage MMD 80
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1997
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Tillots:
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MMM 500 Mobile
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1999
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L' Oreal:
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High shear doublestation
15 / 50 liters
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2003
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Roche:
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Toxic powders processing
MMD 100
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2005
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Lifecore Biomedicals:
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Hyaluron low shear mixing
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2009
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Baxter Bioscience:
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Plasma Thawing Process
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2010
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IPM:
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Silicon Vaginal Devaperine Ring
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2010
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Building Quality into Products |
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Process Analytical Technology (PAT), and QbD techniques, have been promoted by the FDA regulators in order to build quality into products.
Effective PAT implementation is founded on detailed, science-based understanding of the chemical and mechanical properties of all elements of the proposed drug product. In order to design a process that provides consistent product, the chemical, physical, and biopharmaceutical characteristics of the drug and other components of the drug product must be determined. Although the science of analyzing for chemical attributes such as identity and purity is mature, certain physical attributes such as viscosity, homogenising quality and particle size are more difficult to analyze and control.
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PAT: Monitoring Dispersion Homogenization of Semi-Solids: |
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Research from Krieger & the IPT, Institute of Pharma Technology
Krieger and IPT have succesfully concluded a feasabilty study on Ultrasonic resonator Technology to monitor dispersion homogenization. On the coming AAPs show in Washington (23 - 27 October 2011) IPT and Krieger will present to the scientific community a poster on the research findings that includes also a scale up test. The full research paper will be published in the "Journal of Pharmaceutical Science" and will be topic for a special newsletter issue.
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Optimizing a Mixing (Process) Tool by
RAMAN Spectography |
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In order to be able to adhere to QbD specifications of IPM to obtain a mixed end product where an ŤAPIť homogeneously (concentration deviation <2%) needs to be mixed in a high viscosty silicon oil (viscosity over 2 million cps) a RAMAN spectroscopic device was used to optimize the mixing tools.
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