Whitley H135 GMP Isolator

The Whitley H135 GMP Isolator (GB Patent No. 2593277) is designed to fast track your allogenic approval. Experience unrivalled control and consistency through enhanced contamination reduction, cell behaviour control, and cell growth.

The Whitley Difference:

1. Contamination Control: ISO3 unidirectional flow - 100X less particles than Grade A. Crucial for safe and effective ATMPs.
   
   
2. Control & Consistency: Ensure consistent processing with customisable atmosphere control (oxygen, carbon dioxide, humidity, and temperature) for in vivo, low oxygen conditions. Improving control of cell behaviour, proliferation, and differentiation.
   
   
3. Enhanced Cell Growth: large incubation and processing capacity with atmosphere control for increased stem cell production and yields.

Designed to ensure batch-batch consistency for:

• GMP Allogenic Manufacturing.
• Regenerative Medicine.
• iPSC In Vitro Models.
• Tissue Engineering.
• Organoids.
• QC Potency and Efficacy Testing.
• Tumour Microenvironment Assays.

Utilising low oxygen control with ISO 3 (100X less particles than Grade A) laminar flow creating an in vivo environment for optimised stem cell growth.

With a compact and closed design, our re-circulating technology enables our isolators to be housed in Grade D cleanrooms. Helping you develop scalable and cost-effective cleanroom alternatives capable of saving $20,000/m in operations.

Process, incubate and refrigerate your oxygen sensitive products in Grade A conditions without the need to expose cells to atmospheric conditions. Avoiding HIF-1 oxygen shock and contamination risks associated with incubator-BSC transfer.

Gauntlets

GMP regulations require specialised robust gauntlets to be used in GMP high risk processing applications. Our Cell Optimised Isolators are supplied with an innovative quick change ‘BCS’ gauntlet made of non-shedding material allowing easy and rapid glove changes without loss of containment or atmospheric conditions.

MODULARITY

Incubation Module

1. Relative humidity control up to 80%.
2. Incubation at 37°C to support cell growth.
3. CO2 control with 0.1% increments between 0.1% - 15% CO2 in all modules.
4. O2 control with 0.1% increments between 0.1% - 20% O2 in all modules for hypoxic stem cell culturing.

Cell Processing Module

1. Equipment integration for seamless operation within the isolator.
2. Aseptic transfer system to facilitate use of external equipment inside the isolator.
3. CO2 control with 0.1% increments between 0.1% - 15% CO2 in all modules.
4. O2 control with 0.1% increments between 0.1% - 20% O2 in all modules for hypoxic stem cell culturing.

Refrigeration Module

1. Relative humidity control.
2. Grade A refrigeration for cell culture reagents at 7°C.
3. CO2 control with 0.1% increments between 0.1% - 15% CO2 in all modules.
4. O2 control with 0.1% increments between 0.1% - 20%.