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| home > white papers > The Use of Stainless Steel Equipment Within Laboratories and Clean Rooms - Teknomek Ltd |
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 WHITE PAPERS |
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Teknomek Ltd
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The Use of Stainless Steel Equipment Within Laboratories and Clean Rooms
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Teknomek explains why stainless steel is the material of choice for laboratories and hygienic manufacturing.
Clean and safe environments are essential criteria for compliance with UK Medicines and Healthcare products Regulatory Agency (MHRA) regulations. To support this, furniture and equipment must facilitate Good Manufacturing Practice (GMP) by withstanding thorough cleaning and maintenance.
Stainless steel furniture and equipment helps businesses to meet the stringent hygiene audits set by the MHRA. The material is incredibly versatile when it comes to design, plus is robust enough to withstand the most rigorous of cleaning processes. It is common practice for stainless steel furniture providers to work very closely with their customers to deliver tailor-made solutions that comply with regulatory criteria...
Download this white paper to find out more.
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News and Press Releases |
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3P Biopharmaceuticals appoints José Luis Bartolomé as Operational Excellence Director
[Noáin, Spain, September 30, 2020]3P Biopharmaceuticals (3P), a leading Contract Development and Manufacturing Organization
(CDMO) specialized in process development and cGMP manufacturing of
biologics, appoints a new member to the management team with the
incorporation of José Luis Bartolomé as Operational Excellence and
Continuous Improvement Director.
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White Papers |
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Backward Thinking: The Reverse Engineering of A Pressurized Metered Dose Inhaler
Development of a generic equivalent to a current marketed pressurized metered dose inhaler (pMDI) product brings immense challenges. Thorough analysis is critical to gain a comprehensive understanding of the physical attributes and pharmaceutical performance of the reference marketed product. Many factors need to be assessed, understood and combined in order to successfully develop a generic pMDI which will meet the regulatory and quality requirements as an equivalent product in the anticipated target market.
Significant information about the reference marketed product can be obtained from a thorough review of published literature, specifically the Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL). Additionally, baselining the reference marketed product for pharmaceutical performance offers a working target specification for in-vitro correlation. It will ensure the smoothest possible path to commercialization and maximize return on investment. In addition, baselining of the reference marketed product is done to understand batch-to-batch variability and product performance over the stated shelf life to establish targets for critical quality attributes (CQAs), which can be applied to the generic equivalent pMDI.
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Industry Events |
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12th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology
8-11 February 2021, Vienna, Austria
In continuation of the very successful scientific meetings in Budapest, Paris, Berlin, Florence, Geneva, Barcelona, Malta, Istanbul, Lisbon, Glasgow and Granada, the 12th PBP World will be held in Vienna from 8-11 Feb 2021. This every two year held conference has gained an ever increasing impact among the pharmaceutical scientists: With up to 1000 submitted abstracts and about 1300 participants it has become a well-established major meeting, attracting scientists from all over the world.
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