General

Isolators for cytostatics are designed to protect the operator and to provide clean conditions during cytostatic manipulation. They are produced according to the latest guidelines and standards of SIST EN 12469: 2000 and DIN 12980: 2005.

Advantages

  • Tight construction
  • Laminar flow of air in the working chamber

Working principle

The protection of the operator is provided by

  • Physical barrier between operator and process
  • Supervised underpressure in the isolator
  • System for safe material transfer
  • System for safe changing of gloves
  • System for safe filter exchange
  • Dual HEPA filtration of exhaust air

The protection of the product is provided by

  • HEPA filtration of the supply air
  • Controlled laminar air flow in the working chamber
  • Possibility of bio-decontamination with hydrogen peroxide

Environmental protection is ensured by dual HEPA filtration of exhaust air.

 

 

Control

A touch screen is designed for visualization and more transparent management. It is located on the front of the chamber, near the user. Its basic task is system management, error display and service settings.

 

Specifications

  • Material in contact with the product
    • AISI 316L, polished
    • FDA suitable materials
  • Seals - silicone
  • The front lifting glass is made of tempered safety glass with a thickness of 12 mm
  • Visible external surface brushed
  • Details manufactured according to GMP norms for pharmaceutical production (cleaning corners, treatment, welding, sealing ...)

Options

  • Glove tester
  • Automatic tightness test
  • Bio-decontamination system with hydrogen peroxide
  • RTP port
  • CLS for the output of material
  • Welding tongs for bags
  • Customize the system according to customer needs

Type

MC 12-ISO

MC 15-ISO

MC 18-ISO

Outside dimension

w x d  x h (mm)

2439x833x2492

2749x833x2492

3059xx833x2492

Workplace

w x d x h (mm)

1190x600x600

1500x600x600

1810x600x600

Max. connection power without sockets (W)

800

1400

1400

Max.connection power on socket (W)

550

550

550

Laminar air flow (m/s)

0,4

0,4

0,4

Voltage(V/Hz)

230/50

230/50

230/50

ABS. working filters H14 (dim. mm/pcs)

305x610x69/4

305x610x69/5

305x610x69/6

ABS. exhaust filters H14 (dim. mm/pcs)

305x457x69/2

305x457x78/2

305x457x69/3

ABS. inlet filter H13 86,5x202x600 mm (pcs)

13

16

20

Gloves (pcs)

2

3

4

 

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