RABS

Products / RABS 

cRABS

crabs

Litek Pharma designs and manufactures cRABS equipment for aseptic production processes, adapted to the needs of each customer. Our designs are flexible and adaptable to each project.  cRABS are closed, restricted access barrier systems that serve to effectively protect aseptic production processes, where leak-tightness is not required. Specially designed to be adaptable to pharmaceutical sterile filling lines. 

They are highly effective protection systems for aseptic process protection, including a vertical unidirectional flow generating a grade A zone and including the perimeter enclosure structure with stainless steel structure, glass doors with inflatable seals, glove access and specific material transfer systems.

  • Chamber made of stainless steel AISI 316L, 3mm thick, internal polishing Ra<0.6
  • Compact ventilation module, for recirculation.
  • Tempered glass doors with inflatable gasket seals
  • Gloves access. 
  • Electrical panel incorporated in annex module. 
  • LED lighting
  • Siemens PLC 
  • Main chamber manufactured in AISI 316L stainless steel sheet. 
  • Validatable Electronic Data Recording Software, 21 CFR Part 11, GAMP5. 
  • Viable / and non-viable particle monitoring
  • Temperature and humidity monitoring
  • Temperature and humidity control
  • SCADA system.
  • User Manual
  • Functional Design Specification (FDS)
  • Functional Specification (FS)
  • Hardware Design Specification (HDS)
  • Software Design Specification (SDS)
  • Factory Qualification Test (FQT)
  • Factory Acceptance Test (FAT) 
  • Installation Qualification (IQ)
  • Operation Qualification (OQ) 
  • Site Acceptance Test (SAT)

orabs

Litek Pharma designs and manufactures oRABS equipment for production processes, adapted to the needs of each of our customers. oRABS are open, restricted-access barrier systems that serve to protect production processes.

They are highly effective systems for the protection of aseptic processes, including a vertical unidirectional flow generating a grade A zone and may include perimeter enclosures with stainless steel and glass structure, glove access and specific material transfer systems.

  • Made of AISI 304 stainless steel. 
  • Ventilation through high efficiency EC fans. 
  • HEPA filters.
  • Air speed control. 
  • Filter fouling indicators and signalling. 
  • Built-in electrical panel. 
  • LED lighting 
  • Siemens PLC 
  • Manufactured in AISI 316L stainless steel sheet, or in lacquered steel sheet. 
  • Validatable Electronic Data Recording Software, 21 CFR Part 11, GAMP5. 
  • Viable / and non-viable particle monitoring
  • Temperature and humidity monitoring
  • Temperature and humidity control
  • SCADA system.
  • Stainless steel and glass closures, glove accessible.
  • User Manual
  • Functional Design Specification (FDS)
  • Functional Specification (FS)
  • Hardware Design Specification (HDS)
  • Software Design Specification (SDS)
  • Factory Qualification Test (FQT)
  • Factory Acceptance Test (FAT) 
  • Installation Qualification (IQ)
  • Operation Qualification (OQ) 
  • Site Acceptance Test (SAT)
oRABS

Please do not hesitate to contact us if you require any further information.