Containment is increasingly gaining in relevance in pharmaceutical production. One reason is the growing demand for medication to treat serious illness. In cancer and hormone therapy in particular, the use of High Potency Active Pharmaceutical Ingredients (HPAPI) is on the rise. At the same time, demands are also becoming more challenging: users and the environment should be protected from contact with highly-active substances. And cross-contamination of the product must be prevented in the interests of patients. Fette Compacting offers tableting systems which are optimally tailored to containment requirements.
At the interpack 2017, you can experience a new possibility for implementing containment more simply, safely and efficiently. The world of containment offered by Fette Compacting is already available here.
The Containment Guard is the first quality certificate establishing and documenting the retention efficiency of containment tableting systems prior to the subsequent risk assessment carried out by the operator. The measurement criteria comply with the SMEPAC Directive but the Containment Guard method always includes the entire plant and its process and safety equipment. Furthermore, the test process setup is standardized. Fette Compacting carries out the test in a specially designed room in its Customer Center in Schwarzenbek. The certificate levels are based on the OEB level of the containment pyramid and/or the corresponding PDE values.
Users benefit from safe, simple and swiftly available solutions along the entire life cycle of the plant. The process makes it possible to regard all system components as a whole. This applies in particular to process and safety equipment offered by suppliers as well as the patented Air Management System offered by Fette Compacting. Users thereby receive a solution which is tailored to their requirements – both technically and economically. They invest in an optimal cost-benefit ratio for a sustainable and innovative solution.
Fette Compacting makes containment efficient.
The Containment Guard represents the comprehensive range of containment solutions offered by Fette Compacting. In addition to technical solutions, Fette Compacting also offers extensive international services, training and consulting specifically tailored to the requirements of production under containment conditions. The advantages for drug manufacturers:
- Best operator protection
- Tried-and-tested technology
- State-of-the-art Exposure Management
- Risk-based processes for measurements and plant design
- Standardized processes (reliable, valid, objective)
- Modular containment systems
- Pre-planned systems
- Swift training of operating personnel
- Short lead times to commissioning
Containment technologies have been subject to constant development over the past 20 years. New technologies for safe and efficient pharmaceutical production have constantly been added. Process-integrated containment is increasingly relevant as already indicated today in packaging for tablets and capsules. Find out more about this innovative technological development in the report by Richard Denk, Containment Chair in the ISPE group of experts (D-A-CH) and Sales Manager Containment at SKAN AG.
Highly-active substances are decisive for new therapies in cancer therapy and for contraceptive medicine. The HPAPIs contained therein are used because researchers are developing ever more suitable molecule codes for the receptors using computer-aided simulations. In an expert interview, Prof. Dr. Karl G. Wagner, Professor of Pharmaceutical Technology at the University of Bonn, explains the potential harbored by the tiniest particles and the challenges faced by the production of solid formulations.
According to the 2016 Roots Analysis, the HPAPI market is growing by 10% a year, whereby around one quarter of all medication on the market is already sold featuring HPAPIs. Manufacturers are obliged to adjust to increasingly frequent product changes featuring highly-active substances – without substance residue in the machine affecting other products. So-called cross-contamination can otherwise pose a risk for patient safety and product quality. Fette Compacting offers technologies for effective protection in tableting.
An increase in demand for HPAPIs is accompanied by more demanding requirements concerning user protection. Accordingly, the regulatory authorities commit pharmaceutical manufacturers to ensure safe production conditions in order to protect operating personnel from contamination. In the area of tableting,
the raw material is added to the machine in powder or granulate form before being pressed at high speed. In order to provide users with maximum protection, only a tiny amount of dust may leave the process room. Heinrich Behrmann, Head of Construction at Fette Compacting, explains the consequences for pharmaceutical engineering.
Containment systems are increasingly required to guarantee the high safety standards for users and products alike. Modern methods also permit binding of highly-active substances in powders or granulates in tableting which are then pressed as tablets. In order to ensure protection of both users and the product during this process, containment solutions must be integrated in the entire process cycle and the tableting process should be largely automated. Read here to discover which system goes best with which type of production.
Cleaning in containment: The case study for Wash-in-Place and containment plants at one of the world’s leading pharmaceutical manufacturers indicates what maximum safety requirements need to be complied with in tablet production. Only closed systems protect plant operators from highly-active substances. Find out more about the case study here.
Fette Compacting GmbH
Grabauer Straße 24
Phone: +49 (0) 4151-12 794