HTST Skid – Validatable HTST systems for the Biotech sector
The Suncombe High-Temperature Short-Time treatment systems (also known as HTST or Flash Pasteurization), are quickly becoming an integral part of many biopharmaceutical companies’ viral risk-mitigation strategies for bioburden reduction and viral inactivation.
The systems are configured to rapidly heat the material from ambient, to a pre-determined temperature and then subsequently hold the material at this temperature to reduce or eliminate viable microorganisms and viruses in a liquid under continuous flow conditions, prior to applying cooling to reduce the temperature for process use.
The Suncombe HTST systems have been specifically develop, using robust, proven design principles, the systems are designed around the requirements of the ASME Bioprocessing Equipment standard to ensure that your product is HTST treated in a reliable, repeatable, validatable and auditable manner. Facilities can be incorporated for in built cleaning in place (CIP) and sterilising in place (SIP).
HTST Skid Datasheet
Sanitary 316L stainless steel construction and components: Systems are constructed to the highest sanitary standards with 3.1 material traceability and welding dossier. This ensures a fully validatable and sterilisable, cleanable environment.
Static/Mobile: Static and Mobile versions available.
Treatment Parameters: Variable flowrates, treatment temperature, holding time, outlet temperature. Preset and variable configuration to provide Temperature/Time, f0 or log kill requirements. Temperatures up to 136°C or greater if required.
Siemens PLC and 12” colour HMI with options for larger HMIs: Control hardware is industry standard and supported worldwide by Siemens. Ethernet interface included for transfer of critical operating variables to other systems. Designed to enable integration to third party equipment or higher level control system. Option for Rockwell Allen Bradley.
Suncombe BioSuite software: Control software specification has been developed and proven over many years for HTST applications and includes a wide range of user or administrator configurable parameters to enable customised decontamination profiles. User passwords, Active Directory, Audit Trails, Electronic batch reports for local or network storage are possible. User interface screens and process visualisation is simple, intuitive, clear and comprehensive. Remote access options are possible if required. Software complies with FDA 21CFR and EU GMP regulations.
Fully automated processing: The system provides continuous operation and Suncombe’s BioSuite software enables fully automated treatment.
Fully automated reporting: Electronic pdf reporting included – printed report optional.
Automatic Operation: Automatic Liquid Inlet, Automatic Liquid treatment, Automatic Liquid Discharge, Automatic Alarms and Warnings
Utility Requirements: Systems only require compressed air, water, steam, coolant and electrical utility connections.
Heating Options: Direct steam, indirect steam or low temperature hot water heating for delicate liquids. Options for oil and electrical heating.
Sustainability: Designed for sustainability, options for regenerated and sustainable energy usage.
Continuous monitoring of key parameters: HTST process is highly repeatable and validatable.
Safety: Alarms, interlocks and fail-safe design prevent waste discharge in the event of an unsuccessful treatment. This encompasses scenarios such as power loss and under-temperature events.
Plug ‘n’ Play: Comprehensive in-house testing to ensure fast start up on site.
Covers: The systems are also available with stainless steel or thermoplastic covers’
Compact design: Designed to fit into new facilities or to be retrofitted into existing facilities with limited available space.
Configurable: Based on generic standard modules, we can supply individual units custom designed for your specific requirement.
Cleaning In Place and Sterilising In Place: Prepared for CIP and SIP with optional CIP/SIP System