The STERIBAC® System

The STERIBAC® is a newly designed filter for the pharmaceutical, biotech, and food industry, where CIP and GMP are of specific importance.

Due to stricter laws concerning particle shedding and sterility in the pharmaceutical and bio-process industry, DrM has developed this new type of filtration equipment for reliably clean and sterile solid/liquid separation steps. The system is primarily a derivative of the well known FUNDABAC® filter, which has been applied many hundred times, in different industries, for the filtration of solid particles out of process streams.

The task of scale-up of solid/liquid separation process steps in the pharmaceutical and bio-process industries, must combine sophistication for validatable programming, with simplicity of design and construction.

Designed features envisaged and conceptualized for GMP by regulatory agencies are contained in the bio-engineer's wish list. They are:

A totally enclosed system for high-containment tasks devoid of mechanically moving parts except for valves and pumps
Easy CIP, as well as easy disassembly of all components for inspection
Easy handling of filter cake for washing, drying and discharge
Protection of batch integrity
Programmable SIP by both WFI steam and/or chemical means
Filter media that are fully compatible with the product
Execution for the production of particulate free injectables
Easy discharge of the sterile solid phase into a pre-sterilized container, either in dry or slurried form
All connections of the sanitary tubing to meet O-ring sealed GMP flange requirements
Selection of process-focus sterile pump and instruments