Modular GMP and FDA 21 CFR Part 11 compliant Pure2 Aseptic Isolator with Four Glove Ports by Labconco provides Grade A (ISO Class 5) unidirectional airflow

Pure2 Aseptic Isolator, 2 or 4 Glove Ports, Labconco

Custom-configured product: Please request quote. Lab Equip will contact you for requirements.

GMP and FDA 21 CFR Part II compliant Pure2 Aseptic Isolator designed with a sealed containment system for safe and efficient processing in ISO Class 5 conditions with unidirectional airflow
Modular and customizable design available in two-glove (LSKPURE2GLV) or four-glove (LSKPURE4GLV) configurations
Built-in SKAN nanox catalytic converter requires no connection to external exhaust system
Features: patented skanfog technology, advanced HEPA filtration, unidirectional airflow, H2O2 decontamination, and ergonomic access, includes airflow monitor
Note: when ordering specify glove configurations, airlock (1 or 2), operating pressure (-60 or +60), and customization options

• Material Type: Stainless Steel

• Application: Aseptic Processing and Sterility Testing

• Material: 316L Stainless Steel

• Number of Glove Ports: 2 or 4

• Window Material: Double-glazed safety Glass

• Chamber Width: 56"

• Chamber Depth: 28"

• Chamber Height: 25"

• Unit of Measure: EA

Manufacturer SKU: LSKPURE4GLV

Manufactured By: Labconco

Summary

GMP and FDA 21 CFR Part II compliant Pure2 Aseptic Isolator designed with a sealed containment system for safe and efficient processing in ISO Class 5 conditions with unidirectional airflow
Modular and customizable design available in two-glove (LSKPURE2GLV) or four-glove (LSKPURE4GLV) configurations
• Built-in SKAN nanox catalytic converter requires no connection to external exhaust system
• Features: patented skanfog technology, advanced HEPA filtration, unidirectional airflow, H2O2 decontamination, and ergonomic access, includes airflow monitor
Note: when ordering specify glove configurations, airlock (1 or 2), operating pressure (-60 or +60), and customization options

SKAN technology:

Fully integrated skanfog system for H2O2 Decon with 21-minute validated cycle times

Validated skanfog for gene therapy applications

Seamless integration with optional SKAN GT2 wireless glove testers

Patented SKAN H14 FIPA filters simplify safe filter exchanges

Built-in SKAN nanox catalytic converter for connection-free air exhaust system

Applications: cell and gene, sterility testing, biosafety, pharmaceutical manufacturing

Pure2 Compounding Aseptic Containment Isolators (CACIs) for aseptic and aseptic-toxic applications ideal for high-risk or highly potent products

Large airlocks with air shower functionality increase isolator productivity

Selectable positive or negative pressure

HEPA Filtered supply air (H14) and exhaust (dual H14) airflow

Material: 316 stainless steel interior; smooth and easy-to-clean, ABS polymer housing, double-glazed safety glass window

Display: 9" color touch display; user-friendly Siemens PLC, trend, batch, and audit trail data

Standard H2O2 type 1.0 L/ 35%

Standard Gloves: 1-part gloves (butyl)

Customization Options:

SKAN glove testing system, rapid transfer port, custom passthrough, sterility testing pump (Millipore or Sartorius), environmental monitoring, H2O2 decontamination (biosafety, cell and gene applications), H2O2 type 2.5 L/ 35%, configuration for integration of filling equipment, 2-part gloves (butyl glove, CSV cuff) / glove change system

Available Services Include: Installation, MBQ Cycle Development, Factory Acceptance Testing, IQOQ Qualification

(Speak to a Terra product specialist for details about options and customization)

Specifications

• Material Type: Stainless Steel

• Application: Aseptic Processing and Sterility Testing

• Material: 316L Stainless Steel

• Number of Glove Ports: 2 or 4

• Window Material: Double-glazed safety Glass

• Chamber Width: 56"

• Chamber Depth: 28"

• Chamber Height: 25"

• Unit of Measure: EA

• Electrical Specifications: 230 V

• Weight, Product: 2,094 lb

• Dimensions, Product: 85" W x 38" D x 89" H

• Weight, Shipping: 3,395 lb

• Package Type: Palletized

Features and Benefits

Sterility Testing

GMP and FDA 21 CFR Part 11 compliant and designed for easy integration of sterility testing pumps to help reduce false positives in mandatory sterility testing of products

Biosafety

Designed to exceed definition for Class III Biosafety Cabinets with negative pressure operation, glove port testing capability, and integral H2O2 decon for main and transfer chambers

Pharma Manufacturing

Complies with GMP and FDA 21 CFR Part 11, DIN 12980 for aseptic and aseptic-toxic applications performed in pharma manufacturing

Cell and Gene Therapy

Mitigates health and safety risks associated with cell and gene therapy applications with integrated skanfog H2O2 decontamination for operator and environmental protection and reduces transfers to 21 minutes with validated skanfog

Pass-Through Integration

Pure2 Aseptic Isolator with a modular design enables integration of a custom pass-through to maintain aseptic environment integrity and seamless integration of sensors, tools or utilities

Rapid Transfer Port

Designed to deliver reliable, contamination-free material transport in and out of sterile processing environments during active operations.

Sterility Pump Integration

Supports integration with industry-leading sterility pumps, including models from Sartorius and Merck Millipore, to ensure precise, contamination-free fluid handling.

Environmental Monitoring

Supports environmental monitoring systems for particle counting and microbial assessment to ensure air quality and contamination control in aseptic environments.

Installation

Professional installation service available to ensure smooth, complete setup from site preparation to final testing.

Factory Acceptance Testing

Comprehensive Factory Acceptance Testing service offered in Allschwil, Switzerland, featuring one day of hands-on validation to ensure your pure2 meets all specifications.

MBQ Cycle Development

Customized MBQ cycle development service available to optimize your pure2 system's H2O2 performance.

IQOQ Qualification

Installation and Operational Qualification (IQ/OQ) documentation available for pure2 and Wireless GT2 glove tester to ensure regulatory compliance.