LITEK PHARMA isolators cover a wide range of containment applications whose mission is to create a safe environment for operators. Operator safety is crucial due to the toxic nature of the products handled inside.
These isolators make it possible to handle high-potent or highly active products (HAPI), with absolute guarantee for the safety of the operators. Designed and validated (up to) OEB5 (OEL ≤50 ng/m3*)
LITEK PHARMA’s family of isolators are designed according to customer needs and are part of a modular design concept of isolators that allows rapid adaptability to the needs and processes of each customer. The detail and high quality of the mechanical design and manufacture facilitates project development, from conceptual design to qualification.
We have solutions for:
- Safe and ergonomic weighing of high potency active powders. Prioritising operator safety.
- Aseptic applications, maintaining containment levels.
- Loading of reactors, DRUMs, aluminium containers, or filling of any other pharmaceutical format (vials with powder or sterile liquid in collaboration with filling machine manufacturers) in a safe way for the product and the operator.
- Preparation of hospital oncological medicines, guaranteeing the safety of both the operator and the product and its traceability.
- ATEX isolator designs and prepared for the highest OEL requirements.
- Integration of other equipment into the isolator, such as scales, solids transfer systems, micronisers, screeners, grinding discharge, etc.
- Integration with drying equipment, freeze dryers, autoclaves, fermenters, etc.
Chamber made of stainless steel AISI 316L, 3 or 5mm thick, internal polishing Ra<0.6.
Compact ventilation module, for recirculation and aeration.
HEPA filters type BIBO, or PUSH-PUSH.
Tempered glass doors with inflatable gasket seal.
Electrical panel incorporated in annex module.
LED lighting.
Integration of different components, depending on applications:
- IRIS valves for vessel access to the isolator.
- RTP, with split valves for material transfer.
- Drum lifter/turner
- Weighing scales.
- Vacuum product transfer system.
WIP, CIP.
Siemens PLC
Beckhoff HMI industrial PC
Beckhoff 15.6″ touch screen monitor
Material airlock.
Waste exit port.
RTP (Rapid Transfer Port).
Double HEPA H14 filtration.
Validatable Electronic Data Recording Software, 21 CFR Part 11, GAMP5.
Oval gloves.
Temperature and humidity monitoring.
Temperature and Humidity Control.
SCADA system.
Laminar flow.
Turbulent flow.
- 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)
Please do not hesitate to contact us if you require any further information.