ISTE-LIN FILTER

The ISTE-LIN FILTER unit is developed and manufactured to supply effectively and efficiently sterile liquid nitrogen at critical cooling application as well as cryogenic freezing and storage of biological material.

Filter system

A vacuum isolated phase separator, containing sterilizing-grade liquid filters, provides the downstream process with bubbles free sterile liquid nitrogen at constant low pressure.

Sterilizing-grade-liquid filters

The 0.22 μm PTFE membrane filters are validated for sterile filtration of liquid nitrogen. The test protocol is an adaptation of ASTM F838-83, "Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration" and follows the guidelines of PDA Technical report No.26, "Sterilizing Filtration of Liquids"

Steam-in-place

The SIP method used for the sterilization of a ISTE-LIN-FILTER unit is easy to verify. The process is thermally qualified.

Integrity testing

The ISTE-LIN FILTER unit is designed to allow in-line water intrusion testing (WIT) of the filters.

Operation

The process is fully automated and controlled by a PLC. It is divided into 4 modes of operation.

SIP + Drying the unit
WIT of the filters and gaskets
Cooling down the unit and Production of sterile liquid nitrogen
Emptying and Drying the unit

Sterile liquid nitrogem flow up to 3000 Kg/h
Outlet pressure 1.5 barg

The materials in contact with sterile liquid nitrogen are stainless steel AISI 316 or higher
All gaskets are USP class VI validated

Pressure Equipment Directive 97/23/EEC (TÜV approval)
Low Voltage Directive 72/23/EEC
Electromagnetic Compatibility Directive 89/336/EEC

Installation/operation/service manual
P&ID and process description
Component data sheets and certificates
Welding records and certificates
Welding records and certificates
Parameter list