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| home > white papers > Cleaning Validation: What do you need to consider to ensure a successful outcome? - RSSL |
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 WHITE PAPERS |
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RSSL
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+44 (0)118 918 4024
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http://www.rssl.com
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University of Reading, Whiteknights Rd, Reading, West Berkshire RG6 6LA
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Cleaning Validation: What do you need to consider to ensure a successful outcome?
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Cross contamination must be avoided in the Pharmaceutical industry at
all costs and successful cleaning validation ensures that patients are
not put at risk due to cross contamination.
The process can be
divided into a number of sections each of which must be fully understood
and areas of concern addressed to ensure a successful outcome across
the entire process. This spans both the manufacturing and subsequent
analytical and microbological support.
The data used to confirm a
positive/successful cleaning validation is underpinned by the results
of validated analytical methods. It is essential that these results are
truly representative as patient safety is based upon the absence of
equipment residues.
So what are those areas of concern, what
affects your ability to get a successful outcome and what do you need to
consider when carrying out a Cleaning Validation exercise?
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News and Press Releases |
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Sphere Fluidics Closes a $4.8 million USD (£3.7 million) Funding Round
Cambridge, UK, 10 June 2019: Sphere Fluidics, a company commercializing
single cell analysis systems underpinned by its patented picodroplet
technology, announced today that it has closed an additional tranche of
investment of $2.9 million (£2.2 million), securing a total of $4.8
million (£3.7 million) in investment. The funding will be used as
working capital for the Company’s Cyto-Mine® Single Cell Analysis
System, expansion of the UK facility and enable the doubling of
personnel through the opening of a new US Sales Office and Demo Lab in
California.
More info >> |
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White Papers |
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Convergence in the Pharmaceutical Market
PCI Pharma Services
Convergence is currently playing a large part in the growth of the pharmaceutical market. The need for convergence is due to many factors including the declining economy and high competition within the sector. There are many convergences within this sector to date; these include the convergence of food based products with medical and health products and the convergence of prescription drugs to over the counter (OTC) products. Although convergence is helping the pharmaceutical industry expand and develop, it also poses some challenges; these include the regulatory outlook and counterfeiting.
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Industry Events |
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SCOPE Europe – Summit for Clinical Ops Executives Europe
17-18 September 2019, Barcelona, Spain
Building on the success of its long-running US-based counterpart, Summit for Clinical
Trials Operations Executives Europe (SCOPE Europe) is a two-day event serving clinical
innovation leaders, clin ops execs, functional heads, category managers, and those
responsible for the planning and management of clinical trials in Europe and the Rest of
the World. The event will feature opening and closing plenary keynote sessions, five
conference tracks, interactive breakout discussion groups, and networking.
It is an opportunity for leaders from large, mid-sized, and small pharma, specialty
pharma, biotech, vendor companies, and academic research centers to come together to
share best practices and discuss the new era of analytics-driven and patient-centric
trials.
More info >> |
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