>> BETTING ON CHANGE
The industrial plant is outlined to comply with the requirements of current Good Manufacturing Practice and National and International demands.
The strategy is based on the implementation of ISO 9001-2000 regulations and on the approval of the manufacture plant given by the Sanitary Authorities of ANMAT [National Management of Medicine, Food and Medical Technology], MERCOSUR [Common market of the South], IMVIMA [National Institute of Medicine and Food Security], PICs [The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme], EMEA [European Medicines Agency] and FDA [Food and Drug Administration].
>>TECHNOLOGY FOR HEALTH
The general design of the plant has a vertical distribution. In each level, there are two types of corridors, one for materials and one for the staff, where the production in process descends each level, without going through the corridors. In this way, a totally unidirectional flow is obtained with a physical separation of materials and staff.
In the second level, the plant has two elaboration areas and four filtering areas that supply vertically the fractioning or dosage, located at the lower level. The access to these areas is through a scheme of quintuple changing rooms, for the staff entrance and exit.
In the first level, there are the fractioning and dosage areas, with their de-cardboaring support, ampoule washing machines and loading and unloading of sterilizers. The layout is outlined and it has 'HÖLGNER' sterilizers of independent loading and unloading and physically separated, avoiding that the processing product goes back over its steps, and allowing a verified and complete unidirectionality, even in the clean areas. The staff-flow for the entrance and exit of the areas is independent.
At the same time, the plant has encodering, labelling, manual and automatic revising areas 'CMP. PHAR.MA'.
The bulk enters into the corresponding deposit, where later it is fitted in three separate and totally independent packed lines.
The design and distribution of the different areas was conceived from a User Requirement Specification (URS) and then it was challenged in a Design Qualification together with the Engineering Qualifications and Architecture Verifications, done by 'BRANEL Corporation', as an external consultant.
The critical areas are built with pharmaceutical panels 'PHARMA PANEL®', sanitary floors and details that provide highly hygienic, closed and durable surfaces.
All the manufacturing process is monitored automatically. The system allows verifying critical parameters, differential pressures and temperatures in a distal way and in real time.
The critical service systems were developed with worldwide-recognised quality equipment, materials and engineering and state-of-the-art technology.
The air system is made up of nine-air treatment units 'LUWA AIR ENGINEERING-ELECTRA' independent by areas, totally automatic and controlled by a system of plant monitoring 'SCADA' [Supervisory Control and Data Acquisition], fulfilling with all the requirements of ISO 14644 regulation and national regulations.
The independent systems have an automatic compensation of differential pressure and the possibility of partial and divided sanitization and intervention, without affecting the rest of the air units.
The generation, storage, and distribution of compressed air is located entirely free of additives and contaminants. The compressed air is obtained through a state-of-the-air oil-free scroll compressor 'ATLAS COPCO'.
The special gases services (nitrogen and oxygen) are distributed in stainless steel sanitary pipes and online monitored to prevent shortages of supplies.
The water obtaining for pharmaceutical use PW and WFI is generated through advanced technology equipment 'CHRIST WATER TECHNOLOGIES': CEDI (reverse osmosis with electro deionization) and multiple effect distillation, fulfilling the USP32 specifications.
The piping of the water system fulfils the ASME-BPE regulations and the critical parameters of the system such as TOC (Shimadzu) and flow volume (Siemmens), among others, are monitored in a non-invasive and online way.
The water treatment plant has one of the most developed systems of the country with thermal interchanges of loop and stop with Sterilization in Place cycles.
The installed capacity exceeds the 4,000,000 units per month, with the possibility to elaborate batches among 10 and 500 litres of preparation. Moreover, the plant has a wide versatility, being able to manufacture all the injection presentations.
“We are a prepared company to be a reliable and efficient producer, capable of providing our production service with the highest quality and safety expectations on medicinal specialties thanks to our technology, experience, versatility and dedication.”
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