CN103705949B - The off-line sterilizing methods of the respiratory organ on a kind of surge tank - Google Patents

Abstract

The invention provides an off-line sterilization method for the respirator on the buffer tank. Firstly, the combination of the respirator and the respirator hand valve is removed, the mouth of the respirator on the buffer tank is sealed with a stuffy plate, and the buffer tank is automatically cleaned and sterilized ; Then, install an auxiliary hand valve under the respirator hand valve, the respirator hand valve is opened, the auxiliary hand valve is closed, and the respirator, respirator hand valve and auxiliary hand valve are combined as a whole into the sterilization cabinet for sterilization ; After the overall sterilization of the combination of the respirator, respirator hand valve and auxiliary hand valve is completed, remove the auxiliary hand valve under the A-level laminar flow of the filling machine, and then install the combination of the respirator and the respirator hand valve on the buffer on the respirator port on the tank. The method provided by the invention overcomes the deficiencies of the prior art, not only can realize the complete sterilization of the respirator, but also simplifies the sterilization procedure, saves time, improves the production efficiency, reduces the cost, and at the same time can ensure the requirement of sterility .

Description

Off-line sterilization method of a respirator on a buffer tank

technical field

The invention relates to an off-line sterilization method for a respirator on a buffer tank, and belongs to the technical field of filling buffer tanks.

Background technique

The sterilization methods of the respirator on the filling buffer tank are generally divided into two methods: online sterilization and offline sterilization. Sterilization-in-line can reduce the annoyance of human disassembly and installation, as well as possible personnel-involved contamination during the process. However, the buffer tank will be sterilized on-line because the entire tank is under A-level laminar flow, and a large amount of heat will be emitted to the environment during the tank sterilization process, which will affect the local environment of the A-level area to a certain extent. temperature and humidity, which may encourage the growth of microorganisms. And because there are many pneumatic valves in the A-level area in the automatic control system, a certain amount of compressed air will be released from the cylinder of the valve during the valve action, and these gases are often compressed air that has not been sterilized. In this way, the direct release in the laminar flow of the A-level area may pollute the aseptic environment of the A-level area, and the uninterrupted release of compressed air will also affect the stability of the A-level area's laminar flow, making the air flow become turbulent. flow. This will eventually affect the filling environment of the drug, and the sterility of the drug cannot be guaranteed.

Although for automatic on-line sterilization systems, there are also methods such as heat preservation of the buffer tank, leading the exhaust port of the cylinder of the pneumatic valve out of the laminar flow area, or sterilizing the air source of the pneumatic valve, etc., but the whole process It will still affect the environment of the A-level area to some extent. Moreover, the more things there are, the more difficult it is to clean and disinfect the entire equipment and environment, so the offline sterilization method is also highly recommended by many pharmaceutical companies.

Traditional off-line sterilization methods are:

Step 1: Under Class A laminar flow, close the manual diaphragm valve, then remove the respirator and hand valve combination, take it to the sterilizer for off-line sterilization, and seal the respirator port on the buffer tank with a stuffy plate;

Step 2: Pass the sterilized respirator and hand valve combination through the transfer window, and then install the respirator on the buffer tank. At this time, the filter element of the respirator and the upper half of the hand valve are sterilized. The lower half of the hand valve in the closed state is polluted during the transfer process;

Step 3: After the respirator is installed, the buffer tank is automatically sterilized online, so that the lower half of the hand valve connected under the respirator can be sterilized.

The entire buffer tank is removed for offline sterilization, or the buffer tank is sterilized online, and the respirator on the buffer tank is removed for offline sterilization, but the method of removing the entire buffer tank and respirator for offline sterilization is inconvenient to operate, and the buffer The tank is heavy, and the nozzle on the buffer tank needs to be well protected during the transfer and installation process, otherwise it will cause secondary pollution. As for the buffer tank and the respirator on it, if they are to be sterilized separately, the respirator is removed and sterilized offline, and the buffer tank is sterilized online. Later respirators had issues with sterile delivery.

In the traditional off-line sterilization method, in addition to the off-line sterilization of the respirator, the important thing is that the on-line sterilization of the buffer tank must wait for the off-line sterilization of the respirator and hand valve combination to be completed and installed before it can be considered as a whole. Bacteria complete. However, this leads to a delay in the production process, and another hidden danger is that the pressed part of the diaphragm of the diaphragm valve cannot be completely sterilized.

Contents of the invention

The technical problem to be solved by the invention is to simplify the sterilization procedure of the respirator on the buffer tank, reduce the cost, and make the sterilization effect meet the aseptic requirement.

In order to solve the above technical problems, the technical solution of the present invention is to provide an off-line sterilization method for the respirator on the buffer tank, the respirator is arranged on the respirator port on the buffer tank of the filling machine, and the respirator is arranged below Hand valve, it is characterized in that: this method is made up of following 3 steps:

Step 1: Remove the respirator and respirator hand valve combination, seal the respirator port on the buffer tank with a stuffy plate, and then the buffer tank is automatically sterilized online;

Step 2: Install an auxiliary hand valve under the respirator hand valve, open the respirator hand valve, and close the auxiliary hand valve, then put the respirator, respirator hand valve and auxiliary hand valve into a sterilizer to sterilize bacteria;

Step 3: After the overall sterilization of the combination of respirator, respirator hand valve and auxiliary hand valve is completed, remove the auxiliary hand valve under the A-level laminar flow of the filling machine, and then install the combination of respirator and respirator hand valve On the respirator port on the surge tank.

Preferably, the auxiliary hand valve is always in a closed state.

Preferably, in the step 1, the online sterilization of the buffer tank is to sterilize the buffer tank after the combination of the respirator and the respirator hand valve is removed through the circulation of steam inside the buffer tank.

After the off-line sterilization method of the respirator on the buffer tank provided by the present invention is sterilized, the buffer tank, the respirator, and the respirator hand valve under the respirator are all in a sterile state, and then production and filling can be carried out.

The method provided by the invention overcomes the deficiencies of the prior art, not only can realize the complete sterilization of the respirator, but also simplifies the sterilization procedure, saves time, improves the production efficiency, reduces the cost, and at the same time can ensure the requirement of sterility .

Description of drawings

Fig. 1 is the schematic diagram of the first step in the embodiment;

Fig. 2 is the schematic diagram of the second step in the embodiment;

Fig. 3 is the schematic diagram of the third step in the embodiment.

detailed description

In order to make the present invention more comprehensible, a preferred embodiment is described in detail below with accompanying drawings.

Fig. 1～Fig. 3 is the off-line sterilization process schematic diagram of the respirator on the buffer tank provided by the present invention, respirator is contained on the respirator mouth on the buffer tank of filling machine, respirator hand valve is housed below the respirator, The off-line sterilization method of the respirator on the buffer tank is composed of the following 3 steps:

Step 1: In combination with Figure 1, remove the respirator and respirator hand valve combination 1, seal the respirator port on the buffer tank 2 with a stuffy plate, and then the buffer tank 2 can be automatically sterilized online. The online sterilization of the buffer tank refers to the online sterilization of the buffer tank through internal steam circulation after the respirator is removed. This process is carried out in the filling room, but the sterilization outlet is located in other areas. , such as dosing room or bottle washing room, etc.

Step 2: Combined with Figure 2, install an auxiliary hand valve 4 under the respirator hand valve 3 under the respirator, open the respirator hand valve 3, close the auxiliary hand valve 4, and then put the whole into the sterilization cabinet 5 to sterilize bacteria.

Step 3: In combination with Figure 3, after the respirator is sterilized, remove the auxiliary hand valve 4 (the valve is always closed) under the A-level laminar flow 6 of the filling machine, and then put the respirator and the respirator in hand. The valve assembly 1 is installed on the respirator port of the buffer tank 2 . At this time, the buffer tank, respirator, including the entire respirator hand valve under the respirator are in a sterile state, and then production filling can be carried out.

Through the off-line sterilization method of the respirator on the buffer tank provided by the present invention, not only can the complete sterilization of the respirator be realized, but also the buffer tank does not need to wait for the respirator to be sterilized, and then carry out online sterilization together, so that from production In terms of time, it will save time relatively. That is to say, as long as the system is sterilized on-line, the respirator is passed in for aseptic docking, and the whole can enter the production filling state, which improves the production efficiency.

Claims (2)

1. An off-line sterilization method of the respirator on the buffer tank, the respirator is arranged on the respirator mouth on the buffer tank (2) of the filling machine, and the respirator hand valve (3) is provided below the respirator, its characteristics Herein: the method consists of the following 3 steps: Step 1: Remove the respirator and respirator hand valve combination (1), the respirator port on the buffer tank (2) is sealed with a stuffy plate, and then the buffer tank (2) is automatically sterilized online; The online sterilization of the buffer tank (2) is to sterilize the buffer tank (2) after the combination of the respirator and the respirator hand valve (1) is removed, through the internal steam circulation of the buffer tank (2); Step 2: Install an auxiliary hand valve (4) under the respirator hand valve (3), open the respirator hand valve (3) and close the auxiliary hand valve (4), then put the respirator, respirator hand valve (3) The whole combined with the auxiliary hand valve (4) is put into the sterilization cabinet (5) for sterilization; Step 3: After the overall sterilization of the combination of the respirator, respirator hand valve (3) and auxiliary hand valve (4) is completed, remove the auxiliary hand valve (4) under the A-level laminar flow of the filling machine, and then put the The respirator and respirator hand valve combination (1) is installed on the respirator port on the surge tank (2). 2. The off-line sterilization method of a respirator on a buffer tank as claimed in claim 1, characterized in that: the auxiliary hand valve (4) is always in a closed state.