Services




ASEPTIC SKILLS and EXPERTISE
- Simulation and Modeling Heat, Mass and Energy
Transfer Processes via Numerical Techniques
- Microbiological Validation of Sterilization of Products,
Containers, Seals, Equipment, Surfaces & Environments
- Novel Chemical and Biological Integrators of Lethality
- Non-Destructive Integrity Testing Container-Closure
Systems for Hermeticity and Filter Effectiveness
- Residence Time Distributions for Homogeneous and
Multi-Phase Products – Calculations, Normalizations,
Verifications, Visualizations and Validations
- Aseptic Inspections and Manipulations in Inaccessible
Pathways, Locations and Enclosures including Aseptic
Work Zones, without Breaching Sterility
- Failure Mode Effects and Analyses, Process Parameter
Latitude Studies and Reliability Engineering for Hazard
Analysis, HACCP and HAZOP systems
- Optimization of Microbial Inactivation, Quality Factor
Degradation, Package Integrity and Economy
- Designing, Developing, Validating, Filing & Auditing
Aseptic Sub-Systems, Components and Unit Operations:
- Product - Tubes, Coils, Scrapes, DSI’s and Filters
- Package – Pre & Thermo Form, Form Fill Seal &
Sterile Blow Mold
- Fill & Seal – Sterility Maintenance of Work Zones
- Closure – Laminate, Thread, Mold, Weld
- Surface – H2O2, PAA, UV, EtO, Gamma & E-Beam
- Gas – Filter, UV, Incineration & Generation
- Pre-Sterilization and Maintenance of Sterility of
Aseptic Tanks, Routing Valve Clusters, Enclosures,
Cabinets, Tunnels, Sub-Systems
- Independent, Competent and Professional Process
Authority, with Engineering & Microbiology Perspectives;
Recognized by Peers, Industry & FDA
- Confidential domestic and international prior work - new,
upgraded and modified LACF systems, auditing, trouble
shooting, compliance
- Complete calibration, “as built” equipment and P&ID
verification, microbiological validation, documentation and
21 CFR Parts 11 & 113 filing and compliance services
When you must innovate with reliability, in matters of
safety, sterility and compliance, please consider a
professional with the right skills and expertise.
PROCESS TEK - Sterility by Design
Process Development, Validation & Compliance
Aseptic Process-Package Design & Operation
Contamination Control & Maintenance of Sterility
HACCP, HAZOP & Microbial Risk Assessments
Deviation Analysis and Corrective & Preventive Action
Computer Control & Software Verification & Validation
INNOVATION
Sterilization Optimization
Thermal & Irradiation Processes
Labile Emulsions & Powders
Selective & Differential Processing
E-Beam, Microwave and High Pressure Processes
RELIABILITY
Terminal & Aseptic Sterilization
Dosimeter & Parametric Release
Process Isolators & Biological Barriers
HACCP, Sanitation & LACF Audits
Process Authority for Low & High Foods & Juices