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Pharmaceutical Manufacturing and Packing Sourcer
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The manufacture of sterile pharmaceutical products is governed in the European Union by the requirements of EU Good Manufacturing Practice for Medicinal Products. The GMP guide gives very specific details on the environmental and microbial requirements for aseptic processing. However, little or no guidance is given on how to create and maintain the correct level of microbial contamination in the aseptic suite. This article focuses on two important issues - creating and maintaining a spore-free environment and preventing spore contamination that may result from the use of disinfectants.
Control of Bacterial Spores
One of the most difficult requirements in a life science cleanroom is the control of bacterial spores. They can enter the cleanroom on people and on components at a surprisingly high rate. Research has shown that 40 per cent of consumables as they are taken from stores are contaminated with bacterial spores (1). The rest of the study showed that if the transfer disinfection procedure employed comprised of spraying solely with alcohol, only 27.6 per cent of the spores would be removed. The results of the different methods tested are shown in Table 1. Annexe 1 of GMP states that 'transfer of materials into and out of the unit is one of the greatest potential sources of contamination' (2).
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News and Press Releases |
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Pharmaceutical Packaging and Labelling Summit in Zurich; ACG presentation
At next week’s Pharmaceutical Packaging and Labelling Summit in Zurich (18-19 June), Dr. Eugen Hertel from ACG will be speaking on: Challenges for Global Pharma companies to Implement Anti-Counterfeit Strategy for Russian Track & Trace Regulation. This presentation will include details around ‘the fight against counterfeit medicine - there have been and still are worldwide initiatives to make the supply chain and the safety of medicines secure. After large markets such as the USA and Europe passed their laws and regulations for the pharmaceutical manufacturing companies and established the IT infrastructure, Russia is now next on the move.
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White Papers |
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Shipping with Active Packaging Containers: Three Pre-flight Decisions that Impact the Success of High-value Global Shipments
World Courier
It is the dead of winter in the northern hemisphere and the height of summer in the southern, with external temperature fluctuations exceeding 50 degrees. Flight delays have added precious days to the transport of your multi-million dollar shipment of blockbuster drug from South East Asia destined for Russia. In France, the roads are closed for days due to a monster snowstorm, with your irreplaceable shipment of investigational drugs stopped somewhere en route between Paris and the clinical trial site. Will all be lost, or can informed choices made before the shipment departs ensure product safety despite unforeseen circumstances?
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Industry Events |
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SAPHEX 2019
23-24 October 2019, GALLAGHER CONVENTION CENTRE, 10 RICHARDS DRIVE, HALFWAY HOUSE, MIDRAND, 1685, SOUTH AFRICA
SAPHEX 2019 will be held on the 23rd-24th October at the Gallagher Convention
Centre, Johannesburg, South Africa.
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