Sterility Test Isolator
Presentation of the isolator for sterility tests made in EREA Pharma
Isolator for sterility testing
EREA designs and manufactures isolators for aseptic environments, providing strict protection for the product, the operator and the environment by eliminating airborne contamination and contamination by operators.
- Reliable sterile processing and testing (STI)
- Cleanliness class: class A (Iso 5)
- Tightness class: 3 or 2
- Flow equipment: unidirectional (laminar) vertical
- Regulation:
- Temperature
- Pressure
- Overpressure
- Humidity
Customized Technical Solution
Static and Dynamic protection
Quick installation and Implementation
Easy Surface Cleaning
Features
Aeraulics:
- Grade A laminar flow (unidirectional with a velocity of 0.45 m/s ±20%)
- Open loop filtered ventilation
- Environmental quality :
- HEPA H14 filters
- Tightness class 3 (ISO 10648-2)
- Controlled and monitored positive pressure
- Filter clogging control
- Interlocked SAS doors
- Temperature and humidity control
Cleaning and sterilisation:
- Easy manual cleaning of all interior surfaces
- Rounded corners (30 mm radius)
- H2O2 bio-decontamination (DSVA by nebulisation)
Safety:
- Easy glove change
- Easy filter change
- 100% filter integrity test
- Reinforced blow-off in the event of glove tearing (0.4 m/s in the centre of the glove)
Ergonomic design:
- Isolator with configurable designs (1 or 2 airlocks/2, 3 or 4 gloves per chamber)
- Dimmable LED lighting (white + colour)
Construction:
- 100% 316L stainless steel construction (internal roughness: Ra 0.8μm)
- Safety glass panels
- Inflatable seals
- Bulkhead penetrations
Automation:
- Touch screen HMI with data feedback
- Audit trail
Options 1/2
Integration:
- Distribution line (filling / capping)
- Crimping machine
- Robots
- Peristaltic pump
- Environmental monitoring and control (particle counter/aero-biocollector)
- Environmental monitoring and control (temperature, humidity or oxygen)
- RTP port with continuous liner/Beta bag/Beta container
- Scale
- Air treatment unit
- Etc…
Aeraulics:
- Controlled and monitored negative pressure
- Tightness class 2 (ISO 10648-2)
- Closed loop filtered ventilation
Environmental quality:
- ULPA U15 filters
Cleaning and sterilisation:
- H2O2 bio-decontamination (DSVA by gas)
- CIP/SIP with diamond-tipped tank bottom for liquid drainage
- Air and water gun
Options 2/2
Safety:
- Air intake with double filtration
- Air outlet with double filtration
- Air outlet with double filtration (BIBO)
- Glove integrity testing
- Static electricity reduction
Ergonomics:
- 1/1 scale model
- Customised interior layout / dimensions
- Several types of door opening between the SAS and the bedroom
Construction:
- Interior roughness: Ra up to 0.4μm
- ATEX compliant
Automation:
- Isolator integrated equipment on the HMI
- Data transfer to client server
- Batch report
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Sterility Test Isolator
Pharmacology requires sterility tests to be carried out in order to verify the effectiveness of a manufacturing process for pharmaceutical products and to determine their acceptability. Product validation and sterilisation tests must be secure in order to avoid and limit false results. EREA offers you a tailor-made sterility test isolator.
Sterility Test Isolator
The use of a sterility test isolator is highly recommended if you want to control the quality of sterility tests. Performed within the equipment, testing and control take place in an aseptic environment. Any source of external contamination would be immediately detected, guaranteeing the efficiency and integrity of the process.
Equipped with ULPA or HEPA filters to promote air circulation, the isolator is manufactured to the highest pharmaceutical standards. EREA meets the demanding requirements of GMP recommendations and the strict sealing criteria of ISO 14644-7. In all cases, protection of the environment and operators is guaranteed.
The sterility isolator meets the strict requirements of pharmacology. Thanks to this equipment, you can limit the risk of false positive or false negative results, which are costly for your company and delay the product’s authorisation for sale.
Benefits and Applications of Sterility Test isolators
It’s clear that the use of sterility test isolators is essential for guaranteeing the quality and safety of different pharmaceutical products. Sterility test isolators offer a number of advantages, particularly in terms of contamination control and quality assurance.
First and foremost, sterility test isolators are able to create an aseptic environment in which tests are carried out. This minimises the risk of contamination. Equipped with ULPA or HEPA filters, this equipment ensures clean air circulation in compliance with the strictest pharmaceutical standards, such as GMP recommendations and ISO 14644-7 standards. This protection reduces false positives and negatives. You can then be sure of obtaining reliable, reproducible results.
The ease of cleaning and robustness of these tools also ensure simplified maintenance and long life. What’s more, their intuitive user interface and easy integration into existing production lines means they can be set up quickly and operators can be trained more easily.
In terms of applications, these isolators are used in a variety of pharmaceutical processes, including sterility testing of finished products, quality control of raw materials and the handling of toxic or cytotoxic products. Their flexible design means they can be adapted to different laboratory configurations and specific needs, whether laminar or turbulent flow is involved.
Sterility test isolators are therefore essential for pharmaceutical companies seeking to improve their operational efficiency and the safety of their products. They represent a strategic investment in ensuring reliable sterility testing processes that comply with regulatory requirements.
EREA, Manufacturer of Isolators for Sterility Testing
Our solutions enable you to carry out sterility tests on your pharmaceutical products under excellent conditions. With a high level of sterility and safety, our isolators guarantee reliable results. Our technical teams are at your disposal to meet your needs for large or complex products or devices.
EREA specialises in containment solutions. We have developed a range of tailor-made solutions to meet the needs of the pharmaceutical industry. Our isolators can be laminar flow or turbulent flow for sterile processes and tests. We have also developed a range dedicated to handling toxic or cytotoxic products.
All these solutions are the result of research and innovation by our team of experts to provide the best possible response to the challenges facing the pharmaceutical industry.
EREA, Your Expert Partner in Designing your Sterility Test Isolator
EREA specialises in solutions for controlled environments. We offer effective and innovative sterility test isolators. Our products comply with current regulatory requirements.
To provide you with tailor-made isotechnical solutions, EREA has a 2,500 m2 workshop, a highly specialised team and software for aeraulic simulations and 3D visualisation. We have also set up a clean room for full-scale ergonomic testing.
Thanks to our expertise, we can offer you a complete range of isolators, safety cabinets and laminar flow systems. We can also offer you all the equipment you need for ultra-clean air conditioning.
Don’t hesitate to contact us, our experts will quickly provide you with a free, personalised, no-obligation quote.
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