Aseptic Processing Consult
Providing specialist knowledge within aseptic processing
We deliver consulting, project management and support services to customers with existing or future aseptic production facilities.
What We Do
Consulting
We support our customers in taking decisions when designing new or rebuilding existing aseptic facilities. We can provide specialist knowledge within facility layout, flows and equipment.
Process Optimization
We have strong experience in retrofitting existing equipment with barrier systems. Improving the process stability before barrier installation is key and we have the tools and knowledge to help.
Project Management
Our project managers combine project leadership with specialist knowledge of aseptic processing, enabling them to lead technical work packages and complex implementation projects
Production Support
Specialist production and compliance support, including deviations, CAPAs, change controls, documentation and process improvement.
Expertise
Design of aseptic facilities
- Facility layouts and flows
- Conceptual design
- Specification of user requirements and design reviews
- GMP and Annex 1 assessments
- Client side support in all design phases
Hands-on process expertise
- Aseptic filling
- Formulation and compounding
- Freeze-drying
- Powder dosing
- Wash and Sterilisation
- Single Use Systems (SUS)
- New product introduction and technology transfer
- Process validation
Barrier systems
- Barrier-system selection and design (RABS and isolator)
- VHP cycle development and qualification
- Glove management strategy
- Retrofitting existing equipment (RABS)
- Operational readiness and operator training
Equipment implementation
- Supplier management
- Equipment specifications and supplier selection
- Design reviews and risk assessments
- FAT, SAT, commissioning and qualification
- Aseptic Process Simulation (APS / mediafill)
- Ramp up support
Contamination control
- Contamination Control Strategy (CCS) development and implementation
- Environmental monitoring strategies
- Cleanroom qualification
- Aseptic behaviour and gowning
- Container closure integrity (CCI) studies
- Filter selection and filter validation
- Point-of-fill filtration
- PUPSIT
GMP production support
- Deviation investigations, CAPAs and change controls
- SOPs, work instructions and training material
- Inspection readiness
- Process optimisation and troubleshooting using LEAN and six sigma principles
- Filling-line performance improvement
- Specialist support during critical project or production phases
Working at APC
At APC, you work with colleagues who share your interest in aseptic processing. We invest in professional development, exchange knowledge across projects and meet weekly in Copenhagen to learn from each other and stay connected.
Interested in developing your career in aseptic processing? Get in touch.
Learn from the whole team
You can draw on the experience of specialists across APC – not only the colleagues working on your project.
Develop your expertise
We support continuous development through external courses, conferences and regular technical knowledge sharing.
Be part of the team
Our weekly office days provide time for technical discussions, feedback and collaboration beyond individual client assignments.
