Application of Disposable Technology in Aseptic Filling Process _ System

Original Title: Application of Disposable Technology in Aseptic Filling Process After more than 30 years of development, Single-use Technology (SUT) has covered all the operating units of the whole biopharmaceutical process, from upstream cell culture to downstream purification, until the final filling. Compared with the traditional stainless steel system used repeatedly, the disposaing disposable liquid preparation bag, liquid storage bag, high-level buffer bag, disposable bag filter, filling pipeline, disposable sterile connector, disconnector and disposable filling needle. I. Terminal sterilization and filtration The Guidelines for Sterilization and Filtration Technology and Application in the appendix of Good Manufacturing Practice (GMP) stipulates that the release of bacterial gas or liquid shall be considered in the design of filter location, and the area and location of filter installation shall be confirmed according to the product batch, pipeline length,Antivirus Disposable Mask with CE Certificate, installation and sterilization convenience, etc. The integrity of the filter must be tested and documented using appropriate methods immediately after use. Prior to use of the sterilization filter, a risk assessment should be performed to determine whether integrity testing should be performed and whether it should be done before or after sterilization. If a disposable filtration system is used and pre-use integrity testing or flushing is required, additional design considerations include the pressure resistance of the upstream connecting piping, the sterility of the downstream, and the provision of sufficient space downstream (such as the installation of a sterilization-grade barrier filter or a sterile bag of appropriate volume) for venting and draining. II. Background environment of aseptic filling The aseptic filling production of biological agents must be carried out under Class 100 (ISO5, Class A) environment. Generally, the local environment of the filling machine can be divided into Laminar Airflow (LAF), Restricted Access Barrier System (RABS) (Open or closed) and Isolator. Expand the full text ORABS is an open restricted access barrier system, which is the most commonly used filling barrier at present. It is equipped with a glass door, a metal frame and intervention gloves. The top is equipped with a plenum box to provide unidirectional vertical airflow. The top supply air is discharged from the bottom and returned through the B-level background. Figure 2: Open Restricted Access Barrier With the maturity of Isolator technology and the enhancement of risk awareness of production personnel, Full Body Disposable Coverall ,Against Bacteria Breathable KN95 Face Mask, isolators are widely used. The background environment of isolators is Class C or Class D clean area. During the production process, all personnel operations and the transfer of materials/ms with different functions. The whole system realizes the aseptic transmission of multi-pipeline fluid through a stainless steel channel and a pre-sterilization disposable component, and meets various process requirements: 1, same-level wall penetration; 2, cross-level wall penetration; 3, high-activity and low-activity transmission (ADC, etc.); 4, toxic and non-toxic transmission (virus vaccine, etc.).
Figure 4: Sterile Delivery System RTP (Rapid Transfer Port) is an ideal choice for quickly transferring items (liquid medicine, aluminum plastic caps, rubber stoppers, tools, etc.) to and from a controlled environment in an isolator. The RTP system consists of two parts: the alpha port and the beta port. The alpha port is mounted on the door of the isolator in a normally closed sed in the filling pump (peristaltic pump), which is an important factor to determine the filling accuracy. Each filling pump usually has two rollers, each of which consists of 4-8 rollers. Each pump pipe passes through one roller to form a channel, and the last two hoses converge into one channel. The pulse is offset by the superposition of the peaks and troughs of the two channels. The way of filling bag is also a factor affecting the instability of filling accuracy. The commonly used boat type and octopus type can meet the uniform liquid distribution. In addition,Medical Full Body Coverall, the design of the inverted trapezoidal bag body can minimize the waste of liquid medicine. Figure 6: Schematic diagram of filling pipeline 1 This article originates from Shanghai Lechun Biotechnology, from the "Pharmaceutical Industry" platform, please indicate the source for reprinting. Welcome to pay attention to the "Pharmaceutical Industry" public number and get the latest hot topics such as innovative technology and news trends in the pharmaceutical industry. Return to Sohu to see more Responsible Editor:.
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