The Challenge
When a US-based CDMO began expanding its liquid pharmaceutical production, they turned to BMT USA to deliver a custom pure steam generator to meet their high-throughput requirements.
To support this production volume, the steam generator needed to be capable of simultaneously supplying WFI-quality pure steam to multiple pieces of sterile equipment, including a newly purchased BMT USA Combipro 3-in-1 terminal sterilizer. The client specifically sought to centralize their steam supply, utilizing a single high-output unit to feed all process equipment instead of dedicated generators for each machine.
Additionally, a ceiling height restriction of 12 feet at the installation site introduced a potential challenge, as high-capacity steam generators often require more vertical space.
Finally, the system needed to meet specific industry regulations, including EN285 steam quality standards and 21 CFR Part 11 for electronic record-keeping and audit readiness.
The Solution
Capacity and Sizing: To meet the client’s high-throughput requirements, BMT USA engineered a custom 3,600 pound per hour pure steam generator capable of supplying all connected sterilizers and equipment at the accurate pressure with rapid response times. The pressure vessel, steam separation column, plumbing, and framework were constructed to an overall height of 11.9 feet, ensuring the steam generator would fit within the space constraints of the client’s facility.
Optional Equipment: To meet the stringent regulatory requirements of EN285, the generator is equipped with a range of options, including a degassing system to remove non-condensable gases and an EN285 test elbow for validation. A sanitary feed water booster pump system was also added to ensure consistent water pressure, along with a sample port to allow for quick collection of condensed steam samples for quality testing.
Control System: The steam generator’s control system is equipped with an Allen-Bradley CompactLogix PLC and a Hope Industrial panel PC, selected for their operational reliability and non-proprietary architecture. This hardware configuration ensures seamless integration with the facility’s existing network and provides a durable interface capable of withstanding sanitary washdowns. The control system is designed in compliance with FDA 21 CFR Part 11 to ensure secure and traceable electronic records.
The Result
The custom generator was manufactured and will be installed within the available space at the client’s facility. Upon installation, the client will have the capacity to generate enough EN285-compliant pure steam to support their expanding production and meet the increasing demand for US-based pharmaceutical manufacturing.
Centralizing steam production in one unit allows the facility to avoid the increased maintenance and validation work associated with operating individual generators for each piece of equipment, while also saving floor space and simplifying operations. The inclusion of 21 CFR Part 11 compliant controls ensures the client maintains traceable data that is ready for regulatory audits.