Issue link: https://www.e-digitaleditions.com/i/1112785
34 May 2019 Tablets & Capsules Ensuring that all containment technologies are func- tioning correctly is vital for keeping workers safe, main- taining compliance with regulations, and making produc- tion as efficient as possible. A number of approaches are available to monitor containment system performance, from modeling and manual checking to automated assess- ment via a fully integrated system [6]. Manual assessment relies on the judgment of skilled operators and their ability to inspect each containment system on the production line in question. This approach is very labor intensive and requires accurate data recording and interpretation. SMEPAC is only intended to be used as a guide, as it demonstrates how a containment device performs in a laboratory environment. SMEPAC testing in an environ- ment as close as possible to the real-world manufacturing facility is the only way manufacturers can fully under- stand the device performance outside of the laboratory. Despite these drawbacks, it's widely accepted that using SMEPAC ensures good practice when specifying the containment performance of transfer equipment. Interpreting containment performance test results The type of surrogate, or sample material, you use for performance testing has a major influence on the test results. SMEPAC suggests a variety of surrogate powders, including lactose, mannitol, naproxen, and riboflavin. Each of these has varying particle sizes and bulk densi- ties, which can influence the material's detection level and airborne characteristics, affecting the test results. Containment equipment manufacturers commonly use a micronized lactose surrogate, but they may also use vari- ous other grades of lactose or alternatives, such as parac- etamol, that may have a larger particle size distribution than micronized lactose. The equipment end user should ensure that the surro- gate in the laboratory test is comparable to the HPAPI in the product being manufactured. If the two are not com- parable, the differences must be factored into the inter- pretation of the test results. More importantly, when comparing multiple containment solutions of the same technology, the end user should consider this same factor in the final result comparisons. Also, it's possible for test equipment with the same specification to show differing results in the same test due to differences in sampling methods, and different sam- pling devices used under the same test conditions, and even using the same surrogate, can provide significant variability in the sample result. Understanding how each containment solution has been tested and how the per- formance results were obtained can also help manufactur- ers interpret test results. SMEPAC guidance states that there must be a suffi- cient quantity of surrogate being transferred through the device to ensure maximum coverage of product contact surfaces. This guidance is defined by a suggested weight range, which means that testing devices with a variation of powder mass will result in inconsistent results. equipment is constructed with compatible materials. Whether you're dispensing an API from a containment isolator, transferring a preblend via intermediate bulk containers (IBCs) through a milling process, or loading the final blend into a tablet press, the transfer must main- tain containment integrity. A common interface Market diversification has allowed the development of innovative containment technologies, including flexible and rigid barrier isolators and split butterfly valves (SBVs), which are all commonly used throughout the manufacturing process. SBVs act as a common interface between a mobile container, such as a charge bag, charge bottle, or IBC, and the processing equipment. In particular, closed transfer valves such as SBVs are increasingly replacing traditional open transfer tech- niques because they reduce the risk of cross contamina- tion and limit airborne dust. An SBV consists of a passive unit attached to the mobile container and an active unit attached to the processing equipment. When the two units are joined, they form a valve that enables contained and efficient powder transfer. SBVs are available in a range of different sizes suitable for both pilot-scale devel- opment and commercial production and a range of con- tainment performance levels, down to nanograms. Performance monitoring Performance monitoring is critical to ensure effective containment in a pharmaceutical manufacturing environ- ment. Before a manufacturer can implement a new con- trol device such as an SBV in a process, the device should be assessed according to the International Society for Pharmaceutical Engineering's (ISPE's), Standardised Measurement of Equipment Particulate Airborne Concentration (SMEPAC) guideline to determine its par- ticulate containment performance. Photo 3: Wireless monitoring technology provides real-time reporting and data monitoring at a lower cost than manual monitoring and easily accommodates changes to manufacturing setups.