Small Scale Fill & Finish Isolator

Products / Isolators / Small Scale Fill & Finish Isolator

Litek Pharma’s Small-Scale Fill & Finish Isolator is a customized equipment with the possibility to be adapted to different fill & finish process. 

This isolator is adaptable to install any kind of filling machines for vials, syringes, bottles, with liquid or powder substances, in pharmaceutical or biotech industries.

The primary purpose of the Small-Scale Fill & Finish Isolator is to prevent any contamination form external sources, ensuring and guaranteeing the product’s sterility and integrity. In the case of containment needs the Isolator can be configurated to keep the aseptic process and the containment.

Tailored Aseptic Enclosure Our Small-Scale Fill & Finish Isolator stands at the forefront of customization, precisely tailored to accommodate diverse customer requirements. Seamlessly integrating with various filling equipment, it’s designed to match your unique operational needs.

Robotic Precision Experience unparalleled efficiency and precision with our Small-Scale Aseptic Filling Isolator robotic capabilities. From loading to unloading freeze dryers, our solution optimizes the entire process. Whether it’s manual, semi-automatic, or fully automated, our adaptable system ensures a seamless workflow tailored to your preferences.

Gloveless Convenience Embrace convenience and adaptability with our gloveless operations in the freeze dryer section. Small Scale Fill & Finish Isolator’s system offers the flexibility to operate without gloves, enhancing convenience while maintaining a stringent aseptic environment.

Chamber made of stainless steel AISI 316L, 3mm thick, internal polishing Ra<0.6

Electrical panel incorporated in annex module. 

LED lighting

H2O2 disinfection system integrated, with the disinfection cycle development and the decontamination report.

Stand-alone solution with the ventilation system integrated in the isolator. Easy to install.

PLC Siemens or Beckhoff

Industrial HMI

Audit Trail, CFR21 Part 11, GMP guidelines, electronic signature.

SCADA system, Active Directory and Electronic record

GMP guidelines, CFR 21 Part 11, EndraLex Volume 4

Supervisory Control and Data Acquisition (SCADA)

PLC Siemens or Allen Bradley

OPC interface

Integration of filling equipment as turnkey project

Material airlock.

Validatable software 21 CFR Part 11, GAMP5.

Oval gloves

Glove holders for H2O2 disinfection.

Rapid transfer ports (RTP) installation.

Viable monitoring

Particle counter (non-viable)

LITEK Glove testing device.

Robot and conveyor special application.

H2O2 sensors (HC or LC) for isolator chamber or for external security.

User Manual

CE Certificate

Functional Design Specification (FDS)

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.