Frequently asked questions

The Compounder is an automated compounding system used to prepare sterile parenteral medication such as IV bags, elastomeric pumps, cassettes, and syringes. It increases accuracy, traceability, and efficiency while reducing manual handling. It can be placed inside a downflow cabinet, under a hood or (in case of ward preparations) on a desk.

The Compounder is designed for trained pharmacists, pharmacy assistants, and pharmacy technicians working in hospital pharmacy and/or other specialized compounding pharmacy environments.

The Compounder supports the preparation of: IV infusion bags, elastomeric pumps, syringes and cassettes.

The Compounder can process up to 10 preparations per batch, depending on the selected products, containers, and configuration. Each output position contains an individual weighing scale.

The transport syringe cabinet can hold up to eight transport syringes facilitating the use of maximum eight different APIs in one production batch. Up to 24 vials can be loaded on The Compounder for one run.

No. Each transport syringe is dedicated to a single medication type (medication with same concentration and ingredient) but may be used for multiple containers of that same medication.

The Compounder supports standard 50 ml transport syringes from major suppliers like Codan, Becton Dickenson and BBraun. For specific CSTD configurations, 30 ml syringes can be used with an alternative dosing head.

Yes. The system supports Luer-Lock or CSTD connectors from most major suppliers.

Yes. The system is designed to work with a wide range of commonly available vials, bags, syringes, elastomeric pumps, Luer-Lock connectors and CSTDs using dedicated adapters.

A detailed and continuously updated list of compatible consumables is available upon request from The Compounding Company.

No. The Compounder operates needle-free, reducing the risk of needle-stick injuries.

• Orders and batches are prepared in the software
• A picking list is generated
• The machine is loaded following on-screen instructions
• Compounding runs fully automated, the operator can prepare the next run.
• The machine guides unloading, labelling, and cleaning

No. After starting production, the operator is logged out automatically. Progress can still be monitored on the machine screen.

Yes. The Compounder complies with relevant EU directives, including the Machinery Directive, EMC Directive, RoHS Directive, and EU Measuring Instruments Directive (MID), and carries CE+M marking.

The Compounder includes:

• An emergency stop button on the front panel
• Safety sensors on the flow cabinet window
• Safety sensors on the transport syringe cabinet doors

If a safety condition is not met, the machine will not start or will stop automatically.

All input and output containers are identified using RFID and photographed by the vision unit, ensuring full traceability throughout the process.

The system verifies container identity before each extraction and dosing step. If a mismatch is detected, the process stops and the operator is notified.

If enabled, remaining volumes are automatically identified, labelled, and stored with calculated expiration dates.

Liquid transfer is performed volumetrically with step sizes of approximately 50 microlitres, while verification is done gravimetrically using precision weighing units.

All critical steps are logged via software, RFID identification, vision-based image capture, and gravimetric measurements, providing full end-to-end traceability.

Yes. Lot and charge numbers for medications and consumables can be recorded and enforced as mandatory, supporting GMP compliance.

Typical, average hourly output (including loading, unloading, and labelling) is:

• 30–40 IV bags
• 40-80 syringes
• 15-25 elastomeric pumps

Actual throughput depends on volumes, number of vial connections, and local workflow design.

Yes. The Compounder operates fully automated, allowing operators to prepare the next batch or perform other pharmacy/cleanroom tasks during production.

The software is accessed via a web browser using a personal user account. Roles determine which functions are available for the user.

Approvals support GMP compliance and quality assurance. Articles, medications, recipes (how to prepare a medication), and medication orders typically require two (preferably independent) approvals before use.

Yes. The software supports CSV imports and is designed to interface with third-party prescription and pharmacy systems, for example through HL7.

No. The software is deployed on-premises on customer-provided servers and does not require an internet connection for operation.

A dedicated physical or virtual server is required for the software, database, and services. Microsoft SQL is used as the database.

Cleaning is required after each batch. The operator can choose routine cleaning or intensive cleaning with partial disassembly.

Disinfectant wipes or sprays containing isopropyl alcohol are recommended.

Routine daily cleaning typically takes less than 10 minutes. Full cleaning with disassembly takes approximately 30 minutes.

Maintenance is carried out in consultation with The Compounding Company by trained staff of The Compounding Company, an authorized distributor or trained staff of the customer.

The Compounder 10 measures approximately 1200 × 450 × 510 mm (width × depth × height), including the control cabinet. 10 outputs, 24 inputs, 8 transport syringes.

The Compounder 8 measures approximately 1000 × 450 × 580 mm (width × depth × height), including the control cabinet. 8 outputs, 18 inputs, 6 transport syringes.

The Compounder 5  measures approximately 800 × 450 × 580 mm (width × depth × height), including the control cabinet. 5 outputs, 12 inputs, 4 transport syringes.

Preferred work area height >700 mm

For The Compounder 10: The fully assembled system weighs approximately 60 kg. With modular components removed, the weight is around 40 kg.

Yes. The system is designed for use in LAF cabinets and downflow hoods. Cabinets wider than 160 cm and with a working area height above 70 cm are recommended.

The Compounder is designed for pharmacy and cleanroom environments, operating at temperatures between 15–25 °C and humidity levels of 10–85%.

No. Noise levels remain below 70 dB, and power consumption is under 200 W, so it does not affect cleanroom temperature.

Initial installation and first start-up are performed by specialized staff from The Compounding Company or an authorized distributor.

Yes, but only following the transport instructions in the operator manual. The transport mechanism must be secured, and the machine should be lifted by two people.

Follow the on-screen instructions. If the issue cannot be resolved safely, contact technical support at The Compounding Company or an authorized distributor.

Yes. Individual input, output, or syringe positions can be disabled in the software so production can continue with reduced capacity.

The Compounding Company
Phone: +31 (0)23 201 41 52
Email: service@thecompoundingcompany.com

EU legislation that regulates legally relevant measuring instruments, including automated weighing systems.

When it performs automatic weighing without operator intervention as part of a defined process.

Because gravimetric data may support dose verification and release decisions with legal responsibility.

The system’s weighing function has been independently assessed under EU legal metrology.

No. CE covers safety; CE + M covers metrological accuracy and legal traceability.

No. Validation confirms performance, not legal metrology compliance.

No. MID applies to the integrated system, not individual components.

Not automatically, but it significantly increases regulatory and evidentiary risk.

It provides a legally defined, third-party–assessed reference for weighing accuracy.

The full burden of justification rests with the pharmacist or institution.

A system with CE + M marking, Notified Body number, year, and defined metrological parameters.

Pharmacists, QA managers, and institutions responsible for patient safety and regulatory defensibility.