Containment Technology for Solid Dosage Processing

Understanding Containment Containment is an issue in 9 out of 10 cases of solid dosage form production. Containment issues have become a vitally important Containment Experts aspect of solid dosage form production. Active GEA has a long history of expertise in the field pharmaceutical ingredients (APIs) are becoming of containment. The company not only offers a evermore effective, with more than 50% of all new comprehensive range of robust and compliant chemical entities (NCEs) being classified as potent containment products, it also boasts unrivalled (OEL <10 μg/m3); at the same time, the health...

What level of containment do I need? GEA Design for Containment The production of oncology drugs, hormonal products and/or Additional features such as removable hoppers and other highly potent compounds requires particular attention: supplementary extraction provide increased safety for operators it is essential to avoid exposure of the operators to the drug and facilitate cleaning. Solutions range from single-level, simple as well as prevent the cross-contamination of other products application solutions to multiple-level, integrated dispensary manufactured in the same facility. management systems....

CASE STUDY: Containment Project Direct Compression of Hormonal Tablets Wishing to maximize the solid dosage production of a highly potent hormonal product, a leading drug manufacturer tasked GEA with significantly increasing their output, providing a safer and more efficient factory environment and introducing new systems that would replace the existing isolator-based process. The challenge for GEA was to use their product flow and containment expertise to remove as much isolator-based processing as possible, making the production flow more efficient, whilst maintaining the high levels of containment...

How do I optimize the granulation process, and ensure both product and operator safety? Feeding the Granulation Process Process flow interfaces for the granulation area Drawing on its world-class expertise and technologies, GEA The effective and safe transfer of both excipients and active offers an entire range of state-of-the-art process equipment ingredients is essential. A number of options are available: that has been designed and built with system integration in mind. A modular approach allows customers to select standard Gravity feeding: Gravity loading through a discharge station process...

CASE STUDY: Penn Pharma Fully integrated, high-containment, contract drug development and manufacturing After conducting extensive market research, Penn Pharma identified an increased need in the solid dose oncology market for the outsourced development and production of highly toxic drugs. Its production site had been manufacturing potent solid dosage products for more than 20 years but needed additional capacity. Penn Pharma elected to work with GEA because of its proven track record in containment technology and expertise in creating fully integrated production lines. GEA’s approach was to...

How do I eliminate product transfers during granulation? By definition, a single-pot process is contained, making it the The UltimaPro™-HC is equipped with containment tools for first choice for the granulation of highly potent compounds. loading and discharging (Hicoflex®, MC valves, etc.); a full, No transfers are required between process steps, except to validatable CIP system; contained sampling options or PAT for load the raw materials and unload the dry granules (using end-point determination; and an optimized vacuum system with BUCK high containment split-valve technology). This not HEPA...

CASE STUDY: Ranbaxy Laboratories Ltd Top-end containment line for anticancer drugs GEA supplied a complete containment line to Ranbaxy Laboratories Limited (Gurgaon, India) to manufacture highly potent anticancer drugs with an OEL of 1–10 μg/m3. It was essential that the process prevented any cross-contamination in the production area and limited operator Real Daily Intake (RDI) of hazardous substances to well within the Acceptable Daily Intake (ADI). During the selection process, several key equipment features were specified: • all units had to provide full containment the entire process had...

Can I improve tablet press changeover times, even when compressing potent actives? When dealing with highly potent substances, owing to the and cleaning is done away from the tablet press area, allowing complex geometry of tablet presses, compression is the most the machine to do what it has to do — make tablets. challenging stage of the tablet manufacturing process. All GEA MODUL™ tablet presses are based on the company’s Providing both operator and product safety, the ECM can be Exchangeable Compression Module (ECM) concept. easily removed and exchanged with a replacement unit in just 30 minutes...

High-Containment Wash-off-Line (WOL-ECM) TThe WOL-ECM has been specifically designed for tableting operations using highly potent APIs to keep operators safe from harmful compounds, without the use of cumbersome air suits, and prevent cross-contamination. The WOL-ECM maintains the concentration of harmful APIs in the environment around the tablet press below 1 μg/m3. Made from corrosion-resistant materials, the WOL-ECM can be removed from the press and washed separately, using strong detergents, without any risk of damage. Washing takes place in a sealed environment using a special wash skid...

Is there a safe way to transfer highly active substances? Smart Hardware Solutions System Integration with Containment Interfaces (Loading/Unloading) Our distinctive specialization lies in the integration of BUCK containment technology into complete solutions for ® pharmaceutical solid dosage form facilities. With an emphasis on quality and good manufacturing practice (GMP) standards, BUCK® Valve UMC BUCK® Valve UHC BUCK® Valve MC BUCK® Valve HC Hicoflex® Suction Device we are committed to working together with our customers to 10-100 deliver first-class tailored solutions for projects of all...