Our R&D laboratory integrates a GMP Kilo Lab, a key installation that can scale up and produce APIs and intermediates up to 7 kg batch size. The facility is fully equipped for handling HPAPIs and OEB5 compliance.
Its implementation provides great flexibility and agility to manage projects and productions while meeting safety, environmental and product quality requirements.
Our facility is designed to mimic a commercial production plant, ensuring strict compliance with current cGMP and meeting the highest standards in pharmaceutical architecture.
The Kilo Lab can reproduce on a small scale the same operations of the production plant –distillation facilities, chemical syntheses, hydrogenations, etc. It is in the Kilo Lab where it is possible to detect, at an early stage, any aspect that may arise in the production process and resolve it quickly and with minimal resources.
The AGC Pharma Chemicals Kilo Lab cGMP is fully integrated into our Development and Research Laboratory facilities. It has three reactors of 25L, 50L and 70L, with a temperature range of -80°C to 190°C.
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The reactors and filter dryer with a capacity of 80L are all made of Hastelloy, a material which has high temperature and exceptional corrosion resistance. Thanks to this a high number of common chemical reactions can be undertaken, but also reactions with corrosive elements such as fluoride and acid derivatives.
The entire facility complies with the same cGMP standards that govern our production plant and is also equipped for working with high active pharmaceutical ingredients (HAPI) OEB4 (1-10 mg/m3), while also having an isolator for reactions on small-scale trials and dispensing materials.
Kilo Lab for HPAPI Production with OEB5 Compliance
The production environment includes Class D/ISO 8 clean rooms, equipped with 100% fresh air systems filtered through HEPA filters, and is fully compliant with OEB5 handling requirements (0.1-1 μg/m³).
The facility features dedicated airlocks for both material and personnel flow and a mist shower, ensuring controlled access and minimizing contamination risks.
It is also designed for ATEX Zones, allowing safe operations in environments with potentially explosive atmospheres.
Our process equipment includes a 25L/50L/70L reactor, ideal for high-capacity reactions, and a filter dryer capable of producing up to 7 kg of solid product, including cryogenic projects.
The flexible equipment configuration allows for easy dismounting and maintenance.
Additionally, the facility is equipped with a control unit, a safety workbench for lab-scale work and analytical sampling, an isolator for dispensing, and dedicated support areas such as personnel/material airlocks and a washing room – all contributing to a seamless and compliant API and HAPI manufacturing process.
Kilo Lab FAQ´S
1. What is a Kilo Lab and why is it important for API/HPAPI development?
A Kilo Lab is a small-scale cGMP-compliant facility designed to replicate commercial-scale manufacturing processes. It allows safe and efficient production of APIs and intermediates, making it ideal for scale-up, clinical trials, and technical validations.
2. What batch sizes can AGC’s Kilo Lab handle?
Our Kilo Lab can produce batch sizes of up to 7 kg of solid product, using reactors of 25L, 50L, and 70L, depending on project needs.
3. Is the Kilo Lab suitable for High Potency Active Pharmaceutical Ingredients (HPAPIs)?
Yes. The facility is fully equipped for handling HAPIs and HPAPIs, with OEB4 and OEB5 compliance (up to 0.1–1 µg/m³), isolators for dispensing, and strict containment measures.
4. What safety and containment features are in place?
The Kilo Lab includes Class D / ISO 8 clean rooms, HEPA-filtered 100% fresh air systems, dedicated airlocks, a mist shower for decontamination, and ATEX Zone certification for safe handling of explosive or volatile substances.
5. What materials and reactions can be handled?
All reactors are made of Hastelloy, offering exceptional resistance to high temperatures and corrosive chemicals such as fluorides and acid derivatives. The facility supports a broad range of chemical syntheses, including distillations and hydrogenations.
6. Is the Kilo Lab integrated with R&D operations?
Yes. The Kilo Lab is fully integrated within our Development and Research Laboratory, enabling fast detection and resolution of process challenges, and ensuring alignment with project development stages.
7. Does the Kilo Lab comply with cGMP standards?
Absolutely. The entire facility meets strict cGMP guidelines and mirrors the operations and standards of our full-scale production plant.
