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Time is pressing: The new GEA Pharma Separator line "aseptic" with highest cleaning standards supports the vaccine manufacturer Sinovac in the fight against COVID-19
24 Nov 2020
In order to be able to produce a vaccine against the corona virus Sars-CoV-2 in large quantities, quickly and safely, GEA is supplying further separator systems to the Chinese biopharmaceutical company Beijing Sinovac Life Sciences.
GEA Pharma Separator skid aseptic C with fully automatic SIP: Steam-sterilizable and completely sealed, designed for maximum biosafety and containment. (Photo: GEA)
The state-of-the-art centrifuge skid units of the "GEA Pharma Separator aseptic C" series are manufactured according to ASME BPE standards and meet the highest hygienic pharmaceutical requirements with SIP (Sterilizing-In-Place) and CIP (Cleaning-In-Place) cleanability.
The aseptic C line covers a wide capacity range with four bowl sizes. The machines feature a water-cooled and thus emission-free Integrated Direct Drive (IDD) for the highest cleanroom classes. With the CIP cleaning system and the SIP sterilization concept, the machines are an essential part of the demanding production of vaccines - as well as many other pharmaceutical products. "All the drama surrounding the global impact of COVID-19 means that we, as a leading supplier of equipment, process technologies and process solutions, have a special obligation, especially in the pharmaceutical sector, to support our customers in the production of vaccines with reliable, fast and high-quality technological solutions and our decades of experience," says Dr. Markus Kühberger, Director of the Chemical & Pharma Business Line, GEA. "The plug & produce Pharma Separator Skid Units aseptic from GEA are optimally designed for both standard and customized requirements to ensure maximum safety, maximum yield and perfect adaptation to the respective customer process," says Kühberger.
New line as a world first and next step in vaccine production - aseptic processing made easy
With the introduction of the new pharmaceutical separator line "aseptic", GEA offers pharmaceutical customers a new level of performance, clean room protection, validation and cleanability, as now in the Sinovac project. As a result, every aseptic process can reach the next level of safety.
Four different bowl sizes for each capacity - optimum yield with optimized bowl design
With four different bowl sizes, the capacity of each customer process can be met. Depending on the product, the four bowl sizes are suitable for processing capacities of up to 12000 l/h. The bowl design is conceived with a highSigma variant (large clarifying area, small solids space) for up to 5 vol% or a highVol separator bowl variant (larger solids space) for solids up to 10 vol%. This enables an optimal yield by adapting to the respective product to be processed.
Smooth handling
Shear-sensitive products are gently fed to the filled drum by the patented hydrohermetic feed system below the liquid level and gently accelerated at the axis of rotation.
Integrated direct drive for high clean room classes
The new state-of-the-art IDD drive with a water-cooled motor and a closed housing prevents particle emissions into the clean room. Fewer parts mean fewer wearing parts and easier machine maintenance.
GEA supplied separator to Sinovac already in summer 2020
Already in July 2020, Separation & Flow Components Technologies business unit delivered a CSC 6 centrifuge to Sinovac Life Sciences. This is also a disc centrifuge. GEA developed the machine for the pharmaceutical biotechnology industry according to the current cGMP ("Clinical Good Manufacturing Practice") requirements. The CSC 6 machine is manufactured in a steam sterilizable version (SIP up to 2.5 bar/137°C) for aseptic processing. It has a fully automatic on-site cleaning program (CIP, "Clean-in-Place") and is designed in a hygienic, highly polished design. The hydrohermetic inlet system patented by GEA ensures gentle treatment of shear-sensitive products. The plant is driven by a 3-phase alternating current motor. All parts in contact with the product are made of high-alloy stainless steels. The seals comply with FDA and USP Class VI requirements.
At a glance:
The scope of the GEA Pharma Separator "aseptic" line
- Clarifier skid for solids contents of 5 to 10 vol%
- Nozzle separator skid unit with new GEA flexicon nozzle for solids contents of 10 to 35 vol% and even more, depending on the product. Infinitely adjustable even during production.
- Separator Skid Unit with GEA flexChange concept for solids contents from 5 to 35 Vol% and more, depending on the product. Transforms a static process line into a flexible one.
Features and benefits
- High separation and separation efficiency
- Gentle product handling in the inlet
- Automatic SIP
- Automatic CIP
- Hygienic surface design
- ASME BPE Design
- Patented laser-welded plate lugs (gap-free)
- large capacity range, two basic versions, four drum sizes
- Integrated direct drive IDD
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