Tema Sinergie

Barrier Isolation Technology

In the recent years, there has been a growing demand for high level products and operators protection systems in the global pharmaceutical market, an ever-increasing trend which has lately reached its highest peak.
Tema Sinergie has got over 27 years of experience in manufacturing high-quality stainless steel shielded isolators for the nuclear market, and it is now also able to provide customized barrier isolator systems for aseptic and containment processes dedicated to chemical and pharmaceutical applications.

The barrier isolator systems, or simply isolators, are equipments that set a physical barrier between a lab operator and a work process. They are used in several different industry branches, from orange juice filling lines to cytotoxic drug compoundings to electronics manufacturing.

A barrier isolator is used to create a contained environment around a single process, after which both products and materials are transferred in and out of the isolator through dedicated systems that safely contain the potent material. The operators access the inside of the isolator via glove ports.

The current Pharmaceutical Manufacturing Procedures are subject to Food and Drug Administration (FDA) or Europe, Middle East and Africa (EMEA) regulatory guidelines, focusing on Product Sterility Assurance as well as understanding the safety and health needs defined under Control of Substances Hazardous to Health (COSHH), and Occupational Safety and Health Act (OSHA) considering the wide requirement for Operator and Environment protection.

The use of cleanrooms for aseptic filling and processing is going to decrease, following an inversely proportional trend related to the isolator systems demand. Some of these products will require specialty environments as low relative humidity or low oxygen levels, that are best handled by an isolator.

Tema Sinergie takes advantage of a remarkably experienced staff gathering technical sales engineers, designers, technicians, fitters, and it keeps improving its manufacturing methods and designs to meet the customers’ expectations.

The turnkey equipment packages are completed with the full implementation of appropriate cGMP/GAMP documentation including IQ/OQ packages, FDS, HDS, SDS, P&ID, and all industry standards ensuring compliance, control and validation of all data submittals.