CLF-IS

Compact laminar flow isolator system.

The Compact Laminar Flow Isolator System is a modular cGMP Class A/ISO 5 isolator system specifically designed for safe handling of hazardous compounds (Chemotherapy, Oncological Applications) in hospital pharmacies.

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KEY FEATURES

  • Fully PLC controlled isolator system
  • Modular configuration concept of the system
  • High Efficiency Particulate Air (HEPA H14) filtration
  • Unidirectional Air Flow
  • Positive/negative pressure gradient achievable
  • View/Access panel latches with integrated safety switches
  • LED lighting system
  • Increased operator safety with better ergonomics

OPTIONAL FEATURES

  • Integrated VPHP generator and distribution circuit
  • VPHP sensor for TLV environment (safety sensor)
  • Integrated Non-viable (Particle) monitoring system
  • Integrated Automatic Glove Leak Testing System (AGLTS)
  • Integrated 21 CFR part 11 compliant paperless graphic recorder
  • Front Sliding Shield for operator protection, for radiopharmaceutical applications
  • Shielded working area for operator protection, for radiopharmaceutical applications
  • VPN connection for a secure and private communication via Internet network–remote access and assistance, updates, maintenance and training

GUARANTEED ASEPSIS

The CLF-IS assures the highest air quality of the isolated environment thanks to:
(1) An engineered filtration system composed by High-Efficiency Particulate Air (HEPA H14) inlet, unidirectional down flow, return, and exhaust filters;
(2) An integrated Vapour Phase Hydrogen Peroxide (VPHP) bio-decontamination system for very fast bio-decon cycle (optional).

MODULAR BASED CONFIGURATION

The system is based on a versatile modular concept: the base isolator configuration is composed of a single 2 to 4-gloves working chamber which can be easily expanded with additional modules. This makes CLF-IS perfectly suitable to every need and process. A select number of available options may be added at a future date.

EASE OF MAINTENANCE

A Virtual Private Network connection allows a secure and private communication via Internet network and provides remote access and assistance, updates and maintenance any time, everywhere.

GLOVE INTEGRITY TESTING

The CLF-IS can be equipped with an integrated Automatic Glove Leak Testing System (AGLTS) which performs an independent leak test cycle for each glove mounted on the isolator system according to the Positive Pressure Decay Method described in the international standard ISO 14644-7 Annex E.5. Wireless Wi-Fi data transmission based on a TCP/IP protocol. Recognition of the glove to be tested by means of Radio Frequency IDentification (RFID) Technology. Detection of holes down to 50μm diameter.

ERGONOMIC DESIGN

Maximizing operators’ effectiveness is essential to minimize the risks of accidents, eliminate unscheduled downtime and boost production quality. Operators are assured the most comfortable working conditions by the outstanding ergonomics of the CLF-IS.

AUTOMATIC LEAK TEST

The CLF-IS is equipped with a routine automatic leak testing system which performs an independent leak test cycle for each chamber according to the pressure change method (5.2) ISO 10648-2:1994(E).

MAXIMUM SAFETY

The Compact Laminar Flow Isolator System assures very stringent containment levels along with a full aseptic environment thanks to a perfect combination of design and manufacturing strategies. The system is equipped with inflatable and static seals, made of FDA-approved silicon compound, to guarantee air tightness Class II (ISO 10648:2). The CLF-IS is therefore the perfect solution to perform antiblastic compounding and chemotherapic manipulation.

ENERGY SAVING

Thanks to the new sustainable low voltage ventilation fans, the isolator has a very low energy consumption throughout its life.

© 2020 TEMA SINERGIE S.p.A
Fiscal Code n. 00970310397
Business Register of Ravenna n. 00970310397  |  R.E.A. 111877
Capital Stock € 2.000.000,00 paid-up