When mixing or blending active pharmaceutical ingredients (APIs) or high-potency APIs (HPAPIs), containment is king. Good laboratory practices (GLP) and the proper equipment designed and calibrated to facilitate GLP when transferring, mixing or blending APIs can reduce product waste, product contamination and minimize lost profit as well as create a healthier, contaminant free environment for lab operators.
Part of every lab’s GLP should be the utilization of contained environmental systems, fume hoods or specialty containment solutions designed to help control the mixing or blending environment, making it more suitable to the delicate task at hand. For powdered APIs, a controlled environment means one free of excess humidity, moisture and other contaminants. With liquid APIs, the best environment will be one free of the risk of contamination as well as the proper airflow within the enclosure that will not cause the APIs to evaporate to quickly.
The key to containment and control is airflow. With properly designed hoods and equipment enclosures, airflow within the unit will contain loose particles, allow liquids to evaporate at normal rates, pull hazardous fumes and particles away from the operator and into a safe disposal area. High quality hoods use face-opening airspeed that will safely contain particles within the unit and keep contaminants out while facilitating a good work environment for the operator, making for easier product handling by the operator while still offering maximum containment.
Traditional fume hoods require face-opening airspeeds at or exceeding 100 linear feet per minute (lfpm). That volume of air moving at such a high rate of speed will encourage liquids to evaporate quickly; disturb balances; cause powder loss from transport containers, mixing vessels and sampling tools; additionally, for equipment operators, the noise and speed of the air within the fume hoods can become exhausting and frustrating to work in.
Specialty hoods and enclosures can reduce the face velocity to 70-75 lfpm or lower, depending on the application, while lessening or even eliminating issues that come with mixing and blending API powders and liquids. By using hoods, enclosures and protected systems that incorporate lower wind speeds and engineered solutions that eradicate the hidden vortices, eddies and cross currents that disturb powders and hasten the evaporation of liquids, labs can better control their loss in material and operator time.
Protected systems are alternatives to clean rooms that incorporate a series of benchtop and freestanding units designed to enclose equipment for measuring, transporting, mixing and dispensing APIs and joined by sealed pass-through chambers can help lab operators exercise greater control over employee safety and final product quality. These joined, protected workstations allow laboratories to be configured in the most efficient way and minimize the necessity of bulky and uncomfortable pieces of personal protective equipment, allowing lab operators to be more comfortable and move more freely about the lab while remaining safe and unexposed to harmful APIs.
Jason Frye produced this story with the assistance of Flow Sciences Inc., which produces containment systems for laboratories, pilot plants and manufacturers. These products are designed to protect operators from exposure to hazardous particulates and vapors while performing delicate operations.