Containment isolator pure²

for hospitalsfor cytotoxicsaseptic

Overview
The pure² isolator is a laboratory isolator designed for safe handling of aseptic and aseptic-toxic processes. It provides enclosed containment with rapid automated H2O2 decontamination using the patented skanfog® technology, a modular plug-and-play design, straightforward installation and integrated exhaust air treatment.

Applications

• ATMPs
• Quality control
• Research
• Hospital & Pharmacy

Key features

• Stainless steel construction: work area and material airlock made of stainless steel (hygienic and corrosion-resistant).
• Quick implementation: standardisation and pre-production reduce delivery and project times.
• Modular design: chambers can be flexibly combined to match different processes and room constraints.
• Cleanroom compliance: meets GMP cleanroom Grade A and ISO 5 requirements.
• Modern control system: Siemens S7-1500 with 9" display, GMP package and local user management.
• Validated software: control and software compliant with GAMP 5 Category 4.
• Regulatory documentation: batch records and audit trails compliant with FDA 21 CFR Part 11; integration with LIMS, EMS or MES possible.
• Maintenance-friendly: all openings accessible from the front, suitable for wall mounting and efficient servicing.

Requirements

• Reliable containment in accordance with GMP and ISO (GMP Grade A / ISO 5).
• Flexible use: supports manual and semi-automated workflows from R&D to production.
• Rapid H2O2 decontamination: automated, reproducible cycles via patented skanfog® technology to reduce setup time and ensure microbiological safety.
• Ergonomics and safety: spacious work area and design features focused on operator safety and comfort.

Functional principle
The pure² isolator is developed for the safe handling of highly potent active substances (e.g., cytostatic drugs and other CMR medicines). It provides maximum protection for product and personnel and can be qualified according to DIN 12980 (including SMEPAC containment test). The system supports containment requirements up to OEB 6.

Technical specification summary
Standards and containment: CFR 21 Part 11; DIN 12980; OEB 6; ISO 5.
Control and software: Siemens S7-1500, 9" display, GAMP 5 Category 4.
Decontamination: automated H2O2 decontamination via patented skanfog® technology.

Technical characteristics / specifications

• 2-glove variant - Outer dimensions (W x D x H) with 2 airlocks: 2811 x 955 x 2277 mm.
• 2-glove variant - Outer dimensions (W x D x H) with 1 airlock: 2196 x 955 x 2277 mm.
• 2-glove variant - Outer dimensions chamber alone: 1581 x 955 x 2277 mm.
• 2-glove variant - Inside dimensions, work zone (W x D x H): 1410 x 715 x 629 mm.
• 4-glove variant - Outer dimensions (W x D x H) with 2 airlocks: 3301 x 955 x 2277 mm.
• 4-glove variant - Outer dimensions (W x D x H) with 1 airlock: 2683 x 955 x 2277 mm.
• 4-glove variant - Outer dimensions chamber alone: 2065 x 955 x 2277 mm.
• 4-glove variant - Inside dimensions, work zone (W x D x H): 1985 x 715 x 629 mm.
• Operation pressure: -60 Pa or +60 Pa (to be defined per installation).
• Power supply (single phase): 220 – 240 VAC / 50 – 60 Hz / max. 3500 W (2-glove) or max. 3800 W (4-glove).
• Containment capability: suitable for applications up to OEB 6.
• Documentation & integration: batch records and audit trails compliant with FDA 21 CFR Part 11; integration options for LIMS, EMS or MES.