PHARMACEUTICAL INDUSTRY - Scope of Technical Services
Working within the pharmaceutical industry, TMC recognizes a facility’s need to have a strategy to evaluate risk in potent compound manufacturing and determine the appropriate engineering controls required to prevent or minimize employee exposure. This planned strategy will also determine if current or planned purchase of equipment will operate at appropriate containment levels. This planned strategy begins with a process surrogate in accordance with the established industry guidelines.
Standardized Measurement of Particulate Airborne Concentration (SMEPAC)
With the advent of potent drugs, the pharmaceutical industry needed work practices for the operator, the drug and environmental protection; manufacturers responded by implementing and validating their containment solutions. To accomplish this , the pharmaceutical industry looked at rigid and disposable containment designs. In the late 1990s, professionals focused on worker exposure measurement as the primary target to qualify containment equipment through workplace outcomes. The method was formalized as the standardized measurement of particulate airborne concentration, later adopted and revised by the International Society for Pharmaceutical Engineering (ISPE). The SMEPAC method and approach addresses the outcome of the operational procedure within a room enclosure. This original SMEPAC document has been revised and is now the Good Practice Guide for Assessing Containment Performance method for evaluating worker outcomes due to all sources of emissions within a single test environment.
Containment System Test Methodology
The manufacture and production of potent and highly potent Active Pharmaceutical Ingredients (API) is becoming commonplace in pharmaceutical and biopharmaceutical industries. The active ingredient can be extremely potent even at a very small quantity, and must be handled with care. Due to hazardous nature of these manufacturing processes, it is quite often necessary to verify the containment performance of API containment systems.
As a leader in this area of containment system testing , TMC provides requisite containment testing using surrogate studies in order to document system performance. TMC designs the strategy for a containment test run and statistically evaluates the data to assist in making important containment and manufacturing business decisions.
TMC’s certified professionals work with each client to identify potential manufacturing risks, plan sampling strategy, conduct exposure assessments, validate laboratory results, develop recommendations, identify process improvements, potential sources of exposure and develop guidance on exposure and engineering controls. TMC’s team of certified industrial hygienists can also use the surrogate sample results to develop scale adjusted potential exposures for API molecules.