Choosing the Right Scale Partner
When Quality is Critical Rely on a Competent Partner
When the Spain-based Reig Jofré Group, a leading European pharmaceutical development and manufacturing company, decided to start exporting to the United States market, adapting its processes and facilities to comply with U.S. Food and Drug Administration (FDA) regulations became a key challenge.
The company chose METTLER TOLEDO to help build a fully compliant new weighing area and ensure a smooth transition to the new weighing operations.
The Reig Jofré Group focuses on four areas: Industrial services, pharma, research and development, and biotech services. At its main production site in Barcelona, the company manufactures freeze-dried and sterile vials as well as liquids, syrups, solids, and semi-solids.
Versatile weighing areas provide enhanced flexibility
Reig Jofré planned to start exporting products to the U.S. in 2014, a move that required a series of changes and adaptations in the laboratory, production facilities, warehousing, and administration to meet the regulatory requirements of the FDA. According to Luis Alonso, Reig Jofré engineering manager, one of the most important projects in this endeavor is to develop a new weighing area that provides sufficient versatility for collaboration with third-party customers. The design of the new weighing areas had to account for material and personnel flows as well as international compliance requirements. Furthermore, seamless connectivity of the weighing equipment and easy integration into existing formulation and inventory management systems were critical.
Based on these prerequisites, METTLER TOLEDO designed three weighing cabins. The first cabin is specifically equipped to weigh products in a sterile environment that can be potentially active in medium degrees.
Safe weighing in hazardous areas
Furthermore, this cabin is adapted to allow the weighing of photosensitive materials. The second weighing cabin is classified as Hazardous Area ATEX Zone 2/22, and enables the weighing of highly flammable materials, such as alcohol. The third weighing cabin is used to weigh oral and topical products. In addition, a separate room has been set up to weigh closed drums that do not need to be opened. That room, in contrast to the three weighing stations, is not under laminar flow. Reig Jofré already used METTLER TOLEDO products and chose it to help plan and implement this ambitious project due to its existing relationship and excellent reputation. Existing KC120 weighing platforms from METTLER TOLEDO were adapted and extended with the Application weighing terminals and X4002SX laboratory balances. That setup is fully compliant with Hazardous Area Zone 2/22, and is seamlessly integrated with existing inventory management and formulation systems. Furthermore, all equipment and software solutions meet the certifications required by FDA regulations. The METTLER TOLEDO Service Team performed all of the calibrations. The team also was awarded the overall service contract.
Combining a broad portfolio and global reach
The decision to select METTLER TOLEDO as the partner for this project was based on three important criteria, says Antonio Ramírez, project manager in weighing at Reig Jofré. “First, we had to meet carefully planned project deadlines to prevent production disruptions when changing from the old to the new system,” he says. “Second, we required an equipment portfolio that fulfills regulatory requirements and Reig Jofré’s high-quality standards. Finally, we required the ability to provide equipment globally while also offering local support at a sales and technical level as well as extensive software knowledge,” says Ramírez. “As important as those abilities is our relationship of mutual trust with METTLER TOLEDO, which certainly helped make this project a success.”
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