Hyde Engineering + Consulting has a knowledgeable staff experienced in multifaceted clean steam sterilization projects throughout the bio-pharmaceutical industry. We offer a range of services to support all aspects of your SIP endeavors. Hyde Engineering + Consulting is particularly proud to offer services specifically concerning post- contamination root cause investigation and prevention, and general overall sterility improvement consultation.
STEAM-IN-PLACE (SIP) SERVICES INCLUDE:
SIP Consultation
- SIP System Design and Specification Review
- Most problems can be prevented at the initial design phase, avoiding the hacksaw approach later on
- SIP Equipment Configuration Evaluation and Analysis
- Assessment of existing equipment for dead leg determination, valve prioritization, and sterile additions optimization
- SIP Cycle Evaluation and Optimization
- Review of existing sterilization cycle for sufficient air removal, steam pressure, exposure time, and system cool down under positive sterile air pressure
SIP Validation
Hyde Engineering + Consulting provides a full service integrated validation approach, including:
- Equipment Commissioning (Decommissioning)
- Sterilization Cycle Development
- Protocol Generation (IQ, OQ, CQ, PQ)
- SIP Study Execution
- Well versed in Test Equipment Set-Up / Programming (Validator 2000 / Kaye Digi) along with Pre-Use Calibration and Post-Use Verification
- Thermal Mapping
- Thermocouple / Biological Indicator Placement
- Heat Distribution Mapping
- Heat Penetration Mapping
- Summary Report Generation
- Final Package Compilation
Download PDF of SIP Services.
Merck & Co., Inc.
Hyde Engineering + Consulting has worked and is working with Merck in the design of several biopharmaceutical manufacturing facilities in West Point, Pa. and Rensselaer, N.Y. We provided design services for such areas as process systems for media preparation, cell culture, primary recovery, buffer preparation and storage, purification, and final bulk filling. JMHC developed process, CIP, and SIP flow paths; prepared overall PFDs and process descriptions; reviewed and revised P&IDs; and designed transfer panels and process/CIP/SIP piping systems.
Human Genome Sciences, Inc.
Hyde worked with Human Genome Sciences, Inc. (HGSI) in the design of two biopharmaceutical manufacturing areas in Rockville, Md. These areas included process systems for media preparation, fermentation, cell culture, primary recovery, buffer preparation and storage, purification, and final bulk filling. Hyde developed overall PFDs, process, CIP, and SIP flow paths; prepared process descriptions and sequences of operations; reviewed and revised P&IDs; and designed transfer panels.
Eli Lilly and Company
In Indianapolis, Ind., Hyde was a consultant to Eli Lilly in the renovation of a fermentation primary recovery and purification facility, and in the design of a new multi-product biopharmaceutical manufacturing process located in an existing facility. We provided consultation for the design of the process, CIP, and SIP piping systems including flow paths and transfer panels with an emphasis on cleanability. We also reviewed piping installation drawings and process equipment designs for cleanability, process, and CIP equipment specifications, and developed functional descriptions for the CIP systems and circuits.