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SKAN pure² laboratory isolator
Controlled aseptic processing. Expertly supported in the UK.
The SKAN pure² is a modular laboratory isolator for aseptic and aseptic-toxic processes, including sterility testing, ATMP processing and the preparation of cytotoxic drugs and CMR medicines.
Combining proven SKAN isolator technology with the scientific, engineering and after-sales expertise of Don Whitley Scientific, pure² provides a flexible solution for protecting products, operators and critical processes.
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Moving from open processing to an isolator?
EU GMP Annex 1 places greater emphasis on contamination control and the use of barrier technologies to separate operators from critical aseptic processes. While it does not mandate isolators for every application, it strengthens the case for moving away from open processing where this can reduce contamination risk.
A closed isolator can provide Grade A conditions within a lower-grade background environment, subject to appropriate risk assessment, qualification and validation. DWS can help you determine whether the SKAN pure² is suitable for your process and facility.
Understanding the Impact of Annex 1 on Isolator Design
SKAN pure²
 | Controlled aseptic processingClosed containment and GMP Grade A / ISO 5 conditions help protect sensitive products and critical processes from contamination associated with personnel and the surrounding environment. |
 | Product and operator protectionSelectable positive or negative pressure operation allows the pure² to be configured around the needs of the application. Integrated exhaust air treatment supports the safe handling of cytotoxic drugs, CMR medicines and other hazardous substances. |
| Reproducible H₂O₂ decontaminationPatented skanfog® technology provides automated and reproducible hydrogen peroxide bio-decontamination of the isolator chamber and airlock, supporting consistent preparation of the working environment. |
 | A system configured around your processThe modular design supports two- or four-glove arrangements and configurable chambers and airlocks. This allows the pure² to accommodate different workflows, material flows and future requirements. |
| Designed for regulated and high-containment processesThe stainless-steel work area and material airlock provide durable, hygienic surfaces for controlled environments. The pure² can support FDA 21 CFR Part 11-compliant functionality and integration with LIMS, EMS or MES systems. For high-containment applications, configurations can be qualified in accordance with DIN 12980 requirements using SMEPAC testing and are suitable for containment requirements up to OEB 6. |
 | Practical implementation and servicingStandardised construction supports straightforward installation, while front-access openings facilitate wall mounting, cleaning and ongoing maintenance. |
Why choose DWS and SKAN?
DWS is SKAN’s specialist UK partner for laboratory isolator projects. Together, we combine established isolator technology with local scientific understanding, engineering expertise and responsive after-sales support.
50 years of SKAN. 50 years of DWS: SKAN brings extensive experience in cleanroom equipment and isolator technology, while DWS has spent 50 years supporting laboratories through scientific knowledge, specialist engineering and dependable service. Scientific understanding as well as engineering expertise: We begin with your application, materials, workflow and contamination or containment risks - not simply a standard equipment specification. UK-based support: Your project is supported by a UK team that you can contact throughout specification, implementation and the ongoing use of your isolator. A long-term working relationship: An isolator project does not end with installation. DWS focuses on the customer experience and ongoing support throughout the life of the equipment. |  |
Proven in real laboratory environments
Technische Universität Dresden selected a modular SKAN pure² configuration to support its work in regenerative therapies.
Discover how the system facilitates its research through the customer case study, installed-system video and testimonial from Dr Freund.
Frequently asked questions
- What applications is the pure² suitable for?
- The SKAN pure² is suitable for sterility testing, pharmaceutical quality control, research and development, ATMP and cell and gene therapy processing, hospital pharmacy compounding, and specialist pharmaceutical manufacturing. It can support manual and selected semi-automated aseptic or aseptic-toxic processes, including small-batch processing and the handling of cytotoxic drugs, CMR medicines and other highly potent substances.
- How is the pure² decontaminated?
- The pure² uses patented skanfog® technology to provide automated and reproducible H₂O₂ bio-decontamination of the isolator chamber and airlock. Cycle parameters must be established and validated for the specific configuration, load and process.
- How much H2O2 is used to decontaminate a pure² isolator?
- The main chamber uses 15 mL and the airlock uses 7.5 mL, based on a sample worst-case load. Cycle requirements must be confirmed for the specific configuration, load and process.
- How does Annex 1 affect organisations considering an isolator?
- Annex 1 requires manufacturers of sterile medicinal products to apply quality risk management and develop an effective contamination control strategy. It states that technologies such as isolators and RABS should be considered to increase protection from potential contamination.
An isolator may reduce reliance on a high-grade background cleanroom, but its suitability, background environment and operating processes must be justified, qualified and validated.
Let’s define the right isolator for your process
Every isolator project begins with the application.
Our UK team will work with you to explore the most appropriate pure² configuration and the practical requirements for implementation and ongoing support.
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