From the first drawing to the first batch.
We can follow a radiopharmaceutical production site through the whole project: design review, equipment specifications, acceptance tests, qualification, process validation, quality documentation and training, up to routine production.
One partner for the whole project.
Each phase can be contracted on its own, or we can take the project from design to routine production. Every activity is carried out according to GMP.
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01
Design and construction
Before and during construction, we make sure the facility and its equipment are built to meet technical and GMP requirements.
Design review
Review and verification of the execution drawings issued by equipment manufacturers and engineering firms.
- Mechanical
- Electrical and plumbing
- Technical gases
- HVAC
- Hot cell placement
- Radiation monitoring
User requirement specifications
URS written for the major critical equipment.
- Facility
- HVAC system
- Synthesis hot cells
- Dispensing hot cells
- Dispensing system
- Particle monitoring
- Building management system
Project management
Site visits at the critical construction steps, working directly with the construction company and the equipment suppliers so that GMP requirements, standards and guidelines are met throughout construction.
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02
Acceptance tests
We follow the equipment from the supplier's factory to its installation on site.
Factory acceptance tests
Review and approval of the FAT protocols provided by the suppliers, assistance on site at the supplier's facility during execution, and final approval.
Site acceptance tests
Review and approval of the SAT protocols, assistance on site during execution, and final approval.
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03
Qualification and validation
Protocols written and executed by us, with the consumables and the calibrated, certified instruments needed for the tests.
Cleanroom validation
HVAC performance qualification protocol and validation of the classified areas of the production laboratory.
Equipment qualification
IQ, OQ and PQ of the critical equipment, up to the final reports.
- Synthesis hot cells
- Synthesis modules
- Dispensing hot cells
- Dispensing systems
- Isolators
- Quality control equipment
Process validation and stability
Writing and execution of the protocols for each product.
- Bioburden
- Process validation
- Media fill simulation
- Product stability study
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04
Quality system
The documents your site needs to operate under GMP, written for your equipment and your processes.
Quality management documents
- Site master file
- Quality manual
- Validation master plan
- Quality risk assessment
Production procedures
Use and maintenance of every piece of production equipment, from the cyclotron and the transfer system to hot cells, synthesis modules, dispensing systems and building management. Flows of personnel, incoming materials and finished products, cleaning of the classified areas, microbial and particle monitoring.
Quality control procedures
Use and maintenance of the quality control laboratory equipment.
- HPLC
- GC
- TLC
- MCA
- Dose calibrator
- Endotoxin tester
- pH meter
- Osmometer
- Incubators
Quality assurance procedures
- Documentation
- CAPA
- Change control
- Deviations
- OOS
- Complaints and recalls
- Release and reject
- Training
- Organisation and job descriptions
- QP delegation
- Data integrity
- Computer system validation
- Radiation protection
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05
Training
On site training of your personnel on the daily work of a cyclotron and PET radiopharmacy.
- Cyclotron operation: target loading, irradiation, transfer
- Preparation of synthesis and dispensing
- Use of synthesis modules
- Use of dispensing systems
- Personnel and material flows for aseptic operation
- Quality control equipment
- Batch records and batch release
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06
Supply and maintenance
Once the site is running, we keep it supplied and maintained.
Starting materials
Materials for routine production, such as cassettes, reagent kits and stable isotopes.
Maintenance
Maintenance of cyclotrons, hot cells and synthesis modules.
Site operations and management.
Assistance on site during the first months after start-up, covering all daily operations of the cyclotron and PET radiopharmacy.
Scope
- Cyclotron operation
- Synthesis
- Quality control
- Dispensing of unit doses and multi-dose vials
- Packaging
- Radiation safety
- Basic maintenance of laboratory equipment
- SOP updates
- Annual requalification
- Instrument calibration
- Technical gases
- Records and data back-up
On request, with our own technical staff for cyclotron operation, production and quality control.
Planning a new site or a qualification campaign?
Tell us where the project stands and what you need, and we will come back with a proposal.