- Создано: 14-10-22
- Последний вход: 14-10-22
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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 disposable system has the advantages of flexible operation, high safety, shortened production cycle and reduced initial investment cost, which can meet the increasing requirements of regulatory authorities for pharmaceutical enterprises to reduce the risk of cross contamination and reduce the cleaning validation. Figure 1: Process Flow Diagram of a Typical Disposable Filling System The preparation filling process comprises semi-finished product preparation, terminal sterilization filtration, aseptic transmission and aseptic filling distribution. The disposable filling system is a pre-validated, pre-installed and pre-sterilized sterile transfer unit, including disposable liquid preparation bag, liquid storage bag, high-level buffer bag, disposable bag filter,Medical Quickly Delivery Antivirus Coverall, 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,Medical Full Body Coverall, 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 ,3 Ply Disposable Protective 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/tools can not destroy the system tightness. Isolators need to be automatically purged with VHP prior to use and verified for repeatability and controllability. Figure 3: Isolator III. Sterile Delivery System The aseptic transfer system runs through the whole aseptic filling production process, and the through-wall cross-level transfer system is a common tool. Compared with the traditional way, which involves a lot of cleaning, sterilization and other steps, the one-time cross-level through-wall system can solve this problem more safely and conveniently. Leclean Pass provides a simple, safe and reliable solution for the transfer of large quantities of fluids in rooms 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 seal, while the beta end for transferring items consists of a flange, seal, and door and is available in stainless steel transfer buckets, plastic transfer buckets, and disposable transfer bags. After the β end part is connected with the α port, the operator opens the RTP door from the inside of the isolator through gloves, and then transfers the pre-sterilized materials to the inside of the isolator to ensure the isolation from the outside during the whole process. Figure 5: RTP (Rapid Transfer Port) IV. Sterile filling bag The disposable aseptic filling bag comprises a high-level buffer bag, a filling pipeline, a filling needle and other components. The high-level buffer bag is a temporary storage bag for the liquid medicine during the filling process. The start and stop of the peristaltic pump are fed back by the weighing sensor on the hanging scale, so as to realize continuous liquid replenishment, maintain stable liquid level height and liquid inlet pressure, and finally ensure good filling accuracy. The filling pipeline includes the inlet pipe before the pump, the pump pipe and the outlet pipe after the pump. The pump pipe refers to a part of the hose squeezed 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 Disposable 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:. zjyuan-group.com
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 seal, while the beta end for transferring items consists of a flange, seal, and door and is available in stainless steel transfer buckets, plastic transfer buckets, and disposable transfer bags. After the β end part is connected with the α port, the operator opens the RTP door from the inside of the isolator through gloves, and then transfers the pre-sterilized materials to the inside of the isolator to ensure the isolation from the outside during the whole process. Figure 5: RTP (Rapid Transfer Port) IV. Sterile filling bag The disposable aseptic filling bag comprises a high-level buffer bag, a filling pipeline, a filling needle and other components. The high-level buffer bag is a temporary storage bag for the liquid medicine during the filling process. The start and stop of the peristaltic pump are fed back by the weighing sensor on the hanging scale, so as to realize continuous liquid replenishment, maintain stable liquid level height and liquid inlet pressure, and finally ensure good filling accuracy. The filling pipeline includes the inlet pipe before the pump, the pump pipe and the outlet pipe after the pump. The pump pipe refers to a part of the hose squeezed 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 Disposable 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:. zjyuan-group.com