Products & Validations

Some of the Most Innovative Products

THEODORICO – A robotic system designed for the preparation of doses inside syringes and/or vials, minimizing exposure to radiopharmaceuticals;

MODUS — A modular dispensing system for back-to-back production for radiopharmaceuticals;

CLIO – A compact, automatic dispenser for fractionating medicinal products into vials and syringes, specifically designed for installation in hot cells;

ALCEO – A unique automatic system for the synthesis and dispensing of tracers derived from solid targets;

IRIS – An automatic system that dispenses and injects the required radiopharmaceutical dose directly to the patient;

WORKFLOW MANAGEMENT SOFTWARE FOR NUCLEAR MEDICINE – A solution designed for nuclear medicine departments in hospitals and clinics, featuring client/server technology for laboratory management, quality control, and validations;

HELIOS – A fully automatic dispensing system for GMP – compliant aseptic processes using vials or syringes;

FLEXYCULT^TM – A modular incubator for individual cell therapy batches, connected to a shared docking station, ideal for expanding cell factory production capacity;

MSTI (Modular Sterility Testing Isolator) – An isolator designed specifically for laboratories that require full aseptic conditions to test the sterility of pharmaceutical products;

BABY PHILL (Small Batch Vial Filling System) – A vial filling line for clinical batches, development batches, and the production of sterile, cytotoxic, liquid, or freeze-dried drugs for the R&D, pharmaceutical, and ATMP sectors.

These products, along with others in the Comecer range, are validated and certified according to GMP (Good Manufacturing Practices) and Medical Device standards, where applicable.

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Pharma and Radiopharma Validations

Validations are a key requirement of Good Manufacturing Practice (GMP), ensuring that each manufacturer identifies and addresses the validation work necessary to control the critical aspects of their operations.

Comecer provides Factory Acceptance Test (FAT) protocol validation for every Hot Cell, Dispensing System, and Isolator. Additionally, Comecer performs Site Acceptance Tests (SAT) and, upon request, supplies Installation Qualification (IQ) and Operational Qualification (OQ) protocols.

The validation protocols ensure that all systems meet the required industry standards for safety, quality, and performance. Such protocols adhere to the following standards:

• ISO 14644: Cleanrooms and associated controlled Environments;
• ISO 10648: Containment enclosures;
• EEC-GMP: Good Manufacturing Practice — Annex 1: Manufacture of sterile Medicinal Products;
• PDA – TR Nr 34: Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products.