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GMP capable isolator providing sterile laminar airflow under strict anaerobic conditions.

Whitley Workstation A135 GMP Workstation

The A135 GMP and A155 GMP Workstations maintain strict anaerobic conditions, operating from two gas supplies for the most effective and efficient running costs. These anaerobic chambers exceed the requirements of Grade A air cleanliness (EU GMP) and ISO 14644-1 Class 3 both at rest and in operation. They combine sterile laminar airflow, positive operating pressure, and physical isolation, to provide highly effective product protection. Due to being a completely closed, re-circulating, isolator system, these workstations can be housed in a Grade D cleanroom during GMP compliant use.

Our manufacturing partner of over 20 years, Don Whitley Scientific, has focused their efforts into developing a new workstation designed for anaerobic processing that can be operated in a GMP environment. This decision was based on many customer inquiries into our market leading HEPA workstations that required more precise air flow technology and software to meet GMP standards. Based on customer feedback and a desire to provide a cutting edge system that presents a new class of anaerobic workstations the A135 and A155 GMP Workstations were designed.

These workstations are ideal for a range of applications such as fecal microbiota transplant (FMT), live biotherapeutics, manufacture of probiotics, biopharmaceuticals and microbiome therapeutics.

An optional HEPA Filtered Airlock is also available, which includes the incorporation of a H14 HEPA filter to ensure 100% reduction in airborne particulate in the airlock over the course of the cycle. This ensures Grade A particulate counts in the main chamber are not compromised.

Each workstation is tested to ensure compliance with the relevant portions of ISO 14644-3. In addition, tests carried out in our own laboratories confirm the integral HEPA filtered laminar flow system meets the requirements set out in BS EN 12469:2000 with regard to protection of the working area from particulate and microbial contamination.

Applications include therapeutic products requiring controlled atmospheric conditions (anaerobic/hypoxic) for manufacture:

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GMP range of workstations are validated to be 99.9997% efficient in a single pass with an H14 filter.

This is the only product providing atmospheric condition control and unidirectional flow.

Chamber

Laminar Flow HEPA Filtration

Operational particulate counts are kept low even when large amounts of particulate is generated.

Benefits of a GMP Isolator Workstation

Clean Room: Cascade Approach

Traditionally ‘cascade’ from class D - >A. This adds significant cost to any project requiring the build-out of several areas for different air classification environments.

Isolator: All-In-One Approach

The air classification required for the background environment depends on design of the isolator and its application. It should be controlled and for aseptic processing it should be at least grade D.

Two Workstation Size Options

Whitley A135 GMP

Accommodates a single user with single transfer airlock. Strict anaerobic conditions in sterile laminar flow environment.

Specs:

Capacity (Liters)	900
HEPA	Fitted as standard
Gas Supply	ANO2/N2
Airlock Cycle Time	120 seconds
Airlock capacity:	10 x 500ml Duran bottles
Airlock Size (liters)	17.50
Dimensions (w/d/h in mm):	1500 x 1130 x 1080
Weight (lbs/kg):	649/295
Temperature range	4ºC above ambient up to 45ºC
Electrical	110 V, 50-60 Hz

Whitley A155 GMP

Accommodates two user with double transfer airlocks. Strict anaerobic conditions in sterile laminar flow environment.

Specs:

Capacity (Liters)	1800
HEPA	Fitted as standard
Gas Supply	ANO2/N2
Airlock Cycle Time	120 seconds
Airlock capacity	10 x 500ml Duran bottles in each airlock
Airlock Size (liters)	17.50
Dimensions (w/d/h in mm):	2940 x 1130 x 1080
Weight (lbs/kg):	1298/590
Temperature range	4ºC above ambient up to 45ºC