One unexpected outcome of the current global pandemic is that the world has received a crash course in basic microbiology. Ask just about anyone, anywhere in the world today, and they can tell you that diseases such as Covid 19 are caused by an organism too small to see, that can be passed person to person without any warning. We have all also been educated that the primary methods of prevention are personal protective equipment (PPE) such as a face mask, routine cleaning and sanitization of our hands, and social distancing. We have been taught that we humans are the main vectors for spreading disease, whether by direct or incidental contact.
These microbiological concepts form the basic principles our industry uses when aseptically manufacturing sterile dosage forms. It has long been understood that human operators represent the highest risk to contaminate our products, with the highest criticality being aseptically manufactured sterile dosage forms. We have therefore designed our facilities, equipment, processes, and procedures to limit the potential impact of the human factor.
We provide our operators with extensive gowning (PPE) covering them from head to toe. We train and qualify them on proper gowning techniques and cleanroom behavior. Frequent hand sanitization is drilled into our operator’s practice, as well as awareness of body and hand placement when in the cleanroom. We design our filling machinery with barrier systems to promote distancing of the human operator from critical exposed surfaces. We even design our processes to include automation to limit the number of operators needed in the aseptic core and lessen the need for operator interventions.
As anyone in our world can testify now, wearing a mask, constant cleaning and sanitizing of our hands, and keeping a safe distance is downright difficult to do constantly in a compliant manner. Masks are uncomfortable, sanitizing is time consuming, and keeping socially distant goes against our human nature.
In aseptic processing, we do not have the option of letting our mask slip a bit, forgetting to sanitize our hands, or socially interacting while we are in the cleanroom. How we conduct ourselves in the cleanroom, especially when required to intervene closer to the process affects the level of risk to the product. Being always aware of the condition of our gowns, placement of our hands, and overall behavior in the cleanroom makes an aseptic operator’s job one of the most difficult in pharmaceutical manufacturing.
Periodic observation of the aseptic behaviors is not only a key part of quality oversight for aseptic manufacturing operations, but is a regulatory expectation. The goal is to provide real-time feedback to the operators, supporting sustained correct aseptic behavior, as well as help solve any issues that arise.
Lachman Consultant Services, Inc. has many years of experience in providing shop floor quality oversight, including hands-on observation of aseptic behaviors. Even in these times when travel is difficult, we can arrange remote options that will allow us to provide real-time feedback on operations in your aseptic core. If you are interested in learning how Lachman can aid your company in setting up a shop floor oversight program or perform remote monitoring of your aseptic manufacturing lines, please contact Mary Oates, Vice President of Compliance Services, at m.oates@staging.lachmanconsultants.flywheelsites.com.
