Comecer (an ATS company), Modular Aseptic Isolator

- Standalone, dual transfer chamber, sterility test or general-purpose aseptic isolator.

• Preowned, tested, delivered, never installed

The system is designed to operate at a positive pressure relative to the installation area.

- Design (see layout attached):

• Transfer Chamber 1 (upstream of Working Chamber)
• Working Chamber with 4 glove ports
• Transfer Chamber 2 (downstream of Working Chamber)
• Decontamination system including distribution system, catalytic converter, with associated transfer lines and accessories (valves, instruments, filters, etc.)

- For introducing liquid products into the Working Chamber, a SART System™ from Sartorius is mounted to the front view panel.

- Sliding trays are integrated in the Transfer Chambers to assist with the exchange of componentry (materials) with the Working Chamber.

- A peristaltic pump head is installed on the tabletop of the Working chamber.

- Decontamination of the isolator is performed with the Comecer VPHP generator by injection of vaporized H2O2 (for standard ~35%).

- The isolator is equipped with H2O2 catalyzers and a H2O2 low VPHP security sensor to complement the VPHP decontamination process.

- The isolator system is designed to be ventilated with prefiltered air taken from and returned to the (Grade D) installation area.

- Materials of construction are compatible with frequent and routine VPHP decontamination cycles, 70%IPA, 0.25% hypo-chlor, or other similar disinfectant/decontamination solutions used in aseptic environments.

• The internal wall surfaces of the isolator and other metallic components within the isolator are constructed with 316L stainless steel with a surface finish of ≤ 32μ-in Ra (0.8 μm Ra).
• The frame and all external panels are robust and constructed from 304 stainless steel with a surface finish of ≤ 48 μ- in Ra (1.2 μm Ra).
• Layout of equipment allows for maintenance and calibration to be completed in a manner that does not pose an ergonomic risk to those conducting the work.

- The aseptic environment and airflow directionality inside the Working Chamber of the isolator is according to Grade A / Class 100 /ISO 5.

- Particle Measuring Systems® viable and non-viable monitoring solutions are fully integrated with the system.

- Comecer ‘Speedy Glove’ Automatic Glove Testing System (AGTS) is included.

- Glove extenders for each glove port are included.

- The system was fully FAT’d, delivered brand new to the U.S. and never installed.  The system is designed to be fully tested and validated to GAMP 5 guidelines.

- The original URS and the Functional Specifications (FS) are available for review.

- FAT documentation and other specific project details are available for qualified buyers upon implementation of a mutual NDA with the current owner and Comecer.

- Utilities:

• Electrical –
• 480 Vac, 3Ph+PE, 60Hz
• Pneumatic-
• The site compressed air supply system is used for the air supply, at 90 psig, for the isolator automation (gasket, valves, etc).
• Class 1.4.1 or better (ISO 8573-1)
• Pressure 90 psig
• Consumption 35 Nl/min
• Air tank min. volume 50 l
• Connection OD 10 mm PU pipe

- Control system:  Allen Bradley; CompactLogix 5380 controller