Standard Production Flow
PHARMA TECHNOLOGYA validated production flow is the guarantee of repeatedly delivering a pharmaceutical product compliant with specifications and GMP norms. From raw material preparation through processing, filling, packaging and storage — every stage of the production flow is monitored to ensure the final delivery of a medicine of the desired quality.
Klarwin integrates the equipment and process solutions from its established global partners, covering the “critical” zones of the production flow, microbiological contamination control, as well as the final product quality control stages that drive overall efficiency.
Process Equipment
Klarwin supplies validated solutions for every stage of pharmaceutical fluid processing — preparation, transfer, sterile filtration or final sterilization in the container. We integrate the equipment from FEDEGARI (autoclaves, isolators, H₂O₂ sterilizers), TECNinox (PW and/or WFI production and distribution installations, sterile product processing installations, 316L stainless steel tanks, CIP/SIP systems, heat exchangers) and Cytiva (filtration systems for retaining mechanical and/or microbial loads on sterilizing filtration membranes at 0.2 μm). Each system is designed to be controlled in terms of critical parameters, with complete traceability and documentation compliant with GMP norms.
Every system is designed for strict control of critical parameters, with full traceability and GMP-compliant documentation.
Quality Control — Finished Products and Primary Packaging
Every finished product and every primary package passes through rigorous inspection before reaching the patient. Klarwin integrates automated inspection and integrity testing systems from Brevetti CEA and Bonfiglioli Engineering:
- Finished product control — high-resolution optical inspection for detecting foreign particles, fill defects, color variations and labeling irregularities
- Primary packaging integrity — vacuum testing, differential pressure measurement and non-invasive methods for detecting micro-cracks and leaks, compliant with international standards
- Headspace gas concentration monitoring in primary packaging containing lyophilized products or powders, via non-invasive HGA (Headspace Gas Analyzer) technology
Serialization and Aggregation
Serialization and aggregation ensure complete traceability across the pharmaceutical supply chain, preventing counterfeiting and enabling full distribution control. Klarwin integrates Antares Vision systems — globally recognized for GMP compliance and EU Falsified Medicines Directive (FMD) conformity:
- Automatic printing and application of unique codes on every package
- High-precision optical verification and parent-child aggregation (units → cases → pallets)
- Integration with existing packaging lines and national/international reporting databases
Smart Data Management
Intelligent data management is a compliance requirement, not an option. Antares Vision platforms collect, centralize and analyze data in real time from production, control and distribution — transforming raw data into actionable decisions.
Validation Services
Validation ensures that critical equipment, processes and systems perform as specified — with reproducible results, fully documented for audit. Klarwin provides complete validation from concept to final documentation:
All documentation is audit-ready, compliant with ISO, GMP and PDA guidelines.
GMP-compliant production, from molecule to patient
From preparation and sterile filtration to inspection and serialization — Klarwin integrates the validated equipment from FEDEGARI, TECNinox, Cytiva, Brevetti CEA, Bonfiglioli and Antares Vision. One partner across the whole production flow.
CONTACT A CONSULTANT
GMP-compliant production, from molecule to patient
From preparation and sterile filtration to inspection and serialization — Klarwin integrates the validated equipment from FEDEGARI, TECNinox, Cytiva, Brevetti CEA, Bonfiglioli and Antares Vision. One partner across the whole production flow.
CONTACT A CONSULTANT