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Cleaning Science

Strengthen your risk-based approach to cleaning validation.

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CIP/SIP, Cleaning Validation, and Risk Assessment Services for Pharmaceutical Manufacturing

Optimize cleaning processes, ensure regulatory compliance, and maximize efficiency.

Expert CIP/SIP Design, Implementation and Monitoring Services.

Just as cleaning has been a core part of Hyde's business since our founding in 1993, so too has been the accompanying science.

Hyde integrates cleaning science into every phase of your program, from developmental studies to hydraulic balancing and cleaning cycle development to cleaning validation and ongoing monitoring. Regardless of which phase of your cleaning program requires attention, Hyde has a team of experts to provide support.
Whether you have an established cleaning program or one under development, Hyde can help.
  • Cleaning validation strategy and masterplan development
  • Cleaning program gap assessment
  • Cleaning process development lab studies
Engineering
  • Facility and Process Design
  • Capacity Analysis and Optimization of Clean-in-place (CIP) and Steam-in-place (SIP) Circuits
  • Process Equipment aseptic and hygienic Design Reviews
  • Aging Facility Remediation and Redesign
  • CIP Skid Specification and Design
  • Development of CIP/SIP Circuitry and Associated Documentation
Site Engineering
  • CIP Cycle Development
  • SIP Cycle Development
Cleaning and Sterilization Validation
  • Development and execution of protocols
  • Concise and accurate reporting

Reach out to the Hyde E+C team for assistance in establishing or optimizing your cleaning programs.

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Expert Advice

#sustainability

CIP cycle optimization is probably the single biggest lever available to any facility striving for sustainability, with large project ROIs measurable in days, not months or years.

Kenneth Pierce, P.h.D.
Technical SME, Europe, Cleaning Validation & Cleaning Science

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Engineering

Drug Substance Manufacturing
Facility Design (EPCMV) Cell Culture
  • China - Confidential Client
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Project

Description

This was a Greenfield multi-product drug substance facility. The facility was designed with hybrid equipment, developing an optimum mix between single use technology and stainless steel equipment.

The equipment systems included media prep, seed and production bioreactors, harvest, buffer prep and hold, upstream purification, downstream purification, bulk drug formulation and fill, buffer preparation.

Results

and Deliverables
  • PROJECT THROUGHOUT
  • 4 x 5000L Cell Culture
  • COMPLIANCE
  • US FDA, SFDA
  • CAPEX
  • $ 68 Million
  • OVERALL
  • 60,000 Sq. Ft.
  • CLEAN ROOM
  • 18,000 Sq. Ft.

Scope Of Services Provided

Protocol development, execution, and summary reports.

  • Basic, Conceptual and Detailed Design (BD, CD, DD)
  • Automation Engineering – Programming Process Modeling, Conceptual Process Design and Layout
  • Basis of Design Report, Cost and Scheduling Process and Clean Utility Equipment Specification
  • 3D Process Equipment and Sanitary Piping Model
  • Automation Specifications and valve matrices
  • Construction Management Support
  • BioReactors: Design and integration of 50L and 200L Single Use Bioreactors, and 1,000L and 5,000L Stainless Steel Bioreactors. Design included process design through PFD, P&ID, scale up and bioreactor specification, piping integrations, automation (specifications and valve matrices).
Current Equipment ID# (PFD Rev 1.0) Type Description Capacity Specified Unit Vessel / Bag (F/M/D) Tote / Rack Mag Stirrer (Bag)
BRV-01 Disposable Bioreactor 50 L D N/A Y
BRV-02 Disposable Bioreactor 200 L D N/A Y
BRV-03 SS Bioreactor 1000 L F N/A N
BRV-04 SS Bioreactor 5000 L F N/A N
BRV-05 SS Bioreactor 5000 L F N/A N
RSV-01 Tank-SS Resin Slurry Tank 700 L F N/A N
Deleted Tank-SS Pool Mix Tank (ProA) 3000 L F N/A N
MPV-02 Tank-SS Media Prep Mix Tank 4500 L F N/A N
MPV-01 Tank-SS Media Prep Mix Tank 1500 L F N/A N
MPV-03 Tank-SS Media Prep Mix Tank 300 L F N/A N
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Solutions in Practice: Real-World Examples

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North America

Expertise in providing tailored solutions from concept to operational systems.

Case Study

Cleaning Verification and Validation

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Case Study

Legacy Cleaning Process Optimization

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Case Study

Drug Substance Manufacturing Facility Design (EPCMV)

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Case Study

Drug Substance Manufacturing Facility Design (EPCMV) Cell Culture

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Browse our

Case Studies

Solutions in Practice: Real-World Examples

North America

Expertise in providing tailored solutions from concept to operational systems.

Cleaning Verification and Validation

Cleaning Verification and Validation

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Download PDF

Drug Substance Manufacturing Facility Design (EPCMV)

Drug Substance Manufacturing Facility Design (EPCMV)

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Download PDF

Legacy Cleaning Process Optimization

Legacy Cleaning Process Optimization

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Download PDF

Triton X Rinsability Study - Wastewater Restrictions

Triton X Rinsability Study - Wastewater Restrictions

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Download PDF

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Browse our

Case Studies

Solutions in Practice: Real-World Examples

North America

Expertise in providing tailored solutions from concept to operational systems.

Cleaning Verification and Validation

Cleaning Verification and Validation

View more

Download PDF

Drug Substance Manufacturing Facility Design (EPCMV)

Drug Substance Manufacturing Facility Design (EPCMV)

View more

Download PDF

Legacy Cleaning Process Optimization

Legacy Cleaning Process Optimization

View more

Download PDF

Triton X Rinsability Study - Wastewater Restrictions

Triton X Rinsability Study - Wastewater Restrictions

View more

Download PDF

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Explore Hyde E+C Services

Expertise in providing tailored solutions from concept to operational systems.

Analytical Laboratory

Ensure methods are validated and your cleaning program is backed by data, with access to the best in the business.
  • Method Validation
  • Recovery Studies
  • Cleaning Optimization
  • MACO Limits Determination

CQV Services

Commissioning, Qualification and Validation. Offering complete support across all industries we serve, spanning from black utilities to purification systems.
  • Cleaning Program Development & support
  • Site Engineering Services
  • Engineering Design Services

Engineering

Skilled at taking your project from concept to operation systems.
  • Feasibility studies
  • Conceptual, Basic and Detailed Design
  • Remediation Studies
  • Assessments

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