Isolator

ISOLATION TECHNOLOGY BY  

Comecer Isolator is designed in order to grant aseptic conditions inside the machine process area and to protect operators from product toxicity. The Quality & Experience in aseptic and isolation respectively of MAR & Comecer are joining together in order to supply to the End User a state of the art equipment, fully integrated and up to date to the latest regulation, such as cGMP, FDA, CE and UL. The field of application is the production of injectable vials for oncologic treatment, this means that both sterility and containment must be kept at once.

 

COMBO MACHINE

 

COMBO MACHINE FOR ASEPTIC FILLING IN ISOLATOR

 

COMBO MACHINE2

 

COMBO MACHINE

Complete Combo Line to handle vials/PFS and cartridges at different speeds. Completely automated system, de bugging, de lidding, robot for nest loading from tubs, IPC check-weighing, vials de-nesting, vials sealing with 100% closure control. Nitrogen purging before, during and after fill. Bung insertion into PFS and cartridges by vacuum or mechanically. Filling system by volumetric syringes (up to no. 5) either SS or ceramic, peristaltic pumps or combination of both systems. Dosing range from 0,1 to 100 ml. Possibility to use all nest design currently on the market. Different versions of M54 machine, from completely manual to semi-automatic and completely automatic. All the machines and their different versions have been studied and developed for O-Rabs, C-Rabs and Isolator technology.

 

 

 

COMBO MACHINE 4Isolator main features:
• Filtration grade with H14 filters IN / OUT
• Exhaust fans positioned in the technical area
• Automatic Shutter gates, for IN / OUT for differential pressure & containment control
• LED lighting, positioned on the outside of the aseptic process area
• Doors with 12 mm thick tempered glass with inflatable gaskets
Glove ports with independent safety barrier
• No return ducts for optimal uniformity of the air flow
• Isolator walls made of 3 mm thick stainless steel AISI 316L with internal finish Mirror Brite
• < 0.3μm and round corners of 20 mm radius
• Spray Balls and Spray guns for facilitating the cleaning and decontamination of the unit at the end of the production
• Integrated Comecer VPHP for automatic sterilization of the equipment
Isolator & filling machine together will satisfy the containment level Class 3, ISO 10648-02

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M.A.R. S.p.A.

Address: Viale Italia, 50 - 20020 Lainate (MI) Italy

Ph: + 39 029375371
Fax: +39 0293753741
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MAR USA Inc.

Address: 80, Oak Street Norwood, New Jersey 07648 - USA

Ph: + 201 7501944
Fax: +201 750 1966
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MAR India Eq. Pvt. Ltd.

Address: 613 Dattani Prism, Vasai (west),
Dist Thane, Maharashtra, INDIA.

Ph: +91 8691031860
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