Pharmaceutical Technology’s informational publications cover a wide variety of topics involving sterile processing. The April issue of the Equipment and Processing Report featured a steam-sampling cart from Buzdar. It is a good example of one of the simple advances in current technology that makes process control more manageable. This manufacturer’s newest piece of stainless steel equipment is touted as requiring “no water”. Obviously it does require access to steam, but it doesn’t need a separate water source for cooling. Instead, this compact and portable machine carries its own refrigeration unit. This adequately cools the condensate and allows testing to be easily carried out at any suitable location.
A steam rated hose is used to connect the equipment to the outlet. The steam line features a pressure transducer that prevents the hose from being disconnected while there is still pressure anywhere in the loop. This increases operation safety for employees. The cart includes a tank that can be removed and drained if it fills with condensate over time. Lockable casters keep the equipment from moving during sampling but allow easy transportation from one location to another. A level gauge ensures that the equipment can be appropriately stabilized before each use.
The programmable logic control on this unit offers step by step guidance and makes the entire sampling process simple. This PLC also displays temperature, pressure, humidity, and other important information. Having all of this data readily accessible helps ensure accurate test results. A heat exchanger works in concert with the water chiller to provide consistent cooling. The system runs on 110 ac power so it can be used with most U.S. electrical outlets.
Why Clean Steam Is Important
Using pure, sterile steam is considered a Good Manufacturing Process (GMP) in the pharmaceutical industry. Clean steam helps prevent contamination during each step of the manufacturing cycle. Injectable solutions, eye drops, and biopharmaceuticals are examples of products that benefit from the use of hot water vapor that does not contain impurities. This steam may be injected into piping or used in autoclaves to sterilize specific components or equipment. It may also be used to add humidity to the air in clean rooms.
Sampling is the method used to determine whether any contaminants are present in the steam delivery system. These impurities might be rust, additives, or microorganisms. Testing is done on a regular basis to ensure that the production process remains sterile. One of the benefits of having a portable unit is the ease of sampling at multiple locations along the line. This offers a more comprehensive overview of the sterility of the entire system.
Reducing the buildup of mineral and other deposits in an autoclave or sterilizer is easier if clean steam is used. Keeping bacteria from being pumped into the chamber is another bonus. Even if the sterilization cycle would kill all of these pathogens, it makes sense not to introduce them in the first place. If you have a clean steam system at your facility and want to know what autoclaves are compatible with it, use our free report as a starting place.
