From the development and manufacture of the product to its packaging and distribution, Rottendorf provides its customers with a range of services, taking responsibility for the entire process throughout the whole supply chain.
Rottendorf uses GMP- and FDA-compliant systems and advanced technologies such as reliable metal detection systems from METTLER TOLEDO to achieve this. Tablex-PRO systems are highly sensitive, reliable metal detection solutions for the inspection of tablets and capsules. The TablexPRO was developed to meet the special requirements of pharmaceutical production.
Each tablet produced is inspected for metal contamination before packaging. The Tablex-PRO is capable of detecting ferrous, non-ferrous and stainless-steel contaminants as small as 0.3 mm — and automatically removes contaminated products from the production process.
“The Tablex-PRO not only improves the quality of our products, it also reduces production costs thanks to its accurate rejection process and quick set-up,” explains Michael Barton, Head of Tablets and Coating at Rottendorf Pharma.
The Tablex-PRO can be quickly configured for each new batch, maximising valuable production time. The rapid set-up time is especially important for a subcontractor such as Rottendorf Pharma, which produces up to 90 different products in a week.
Scheduled performance verification tests are conducted before and after each new batch is produced. Authorised Rottendorf staff login with their individual user names and passwords to perform the verification tests, apply new settings or prepare a batch change.
This provides full audit traceability to support the requirements of 21 CFR part 11. The Tablex-PRO generates reports with access time stamps and employee names, and provides Michael Barton with valuable information regarding operative settings such as process times and compliance performance.
Typically, up to three batch changeovers are performed in one production day at Rottendorf Pharma. At peak times, the contract producer can make up to 400,000 tablets per hour. False rejects or unnecessary downtime can greatly impact the efficiency of production processes.
In addition to extraordinary operational stability and high availability, the Tablex-PRO metal detection solution also has a condition monitoring function. Unplanned downtime can be prevented because the Tablex-PRO system provides advanced warning of potential problems prior to failure.
The Tablex-PRO continually analyses the performance of its most important components and identifies any negative trends. Full-colour histograms are utilised to give an early warning of any changes in detector sensitivity, allowing the operator time to plan for corrective maintenance to be completed.
All recorded metal detection data is collected and can be accessed via an integral Ethernet adapter, enabling connection to the company’s factory management system. Data can also be accessed manually via a USB interface for documentation purposes.
All recorded data and processes, including electronic signatures, are captured and stored for quality management. Thanks to the documentation and data recording functions, the Tablex-PRO helps Rottendorf Pharma to meet its quality requirements to comply with GMP and FDA regulations.
