Production process of tubercle bacillus pre-filled single injection

Abstract

The invention discloses a production process of a tubercle bacillus pre-filled single-person injection, and particularly relates to the technical field of injection production, which comprises the following steps of: 1, transferring a commercially available ready-to-use pre-filled syringe into a filling machine under the condition of A-level laminar flow protection, taking out a sterile nest box syringe from an outer package, and filling the outer package with a sterile nest box syringe; in the whole outer package unpacking process, the outer package is prevented from polluting microorganisms and particles of the nest box and the environment, the outer package needs to be manually cleaned, wiped and disinfected before the outer package is unpacked, and the particles and the microorganisms on the outer package bag are reduced; and step 2, removing the inner bag in a sterile A-level environment. The tubercle bacillus (PPD) pre-filled single injection designed by the invention has the advantages of accurate dosage, convenience in direct injection, no pollution, convenience in transportation and storage, and higher cost performance than a recombinant tubercle bacillus fusion protein pre-filled single reagent (EC reagent).

Description

Technical Field

[0001] The present invention relates to the technical field of injection production, and more specifically, to a production process of a prefilled single-dose tuberculin injection. Background Art

[0002] The full name of PPD reagent is Purified Protein Derivative of Tuberculin. It is a reagent used to detect whether the human body is infected with Mycobacterium tuberculosis. After the PPD reagent enters the human body through intradermal injection, the skin reaction at the injection site is observed to determine whether the person is infected with Mycobacterium tuberculosis. There are two types of PPD reagents: BCG-PPD and TB-PPD. Each ampoule of PPD test reagent is 1mL, and the dose per person is 0.1mL, containing 5IU of UCG-PPD. Each ampoule of TB-PPD is 1mL, and the dose per person is 0.1mL, containing 5IU of TB-PPD. The PPD test is carried out in accordance with the "Clinical Diagnosis and Treatment Guidelines for Tuberculosis". 0.1mL is injected intradermally in the middle and lower 1 / 3 of the palm side of the left forearm. The use of PPD reagent reduces the workload of radiological examinations and unnecessary radiation exposure to minors. It is more in line with the cost-effectiveness principle and makes screening easier and safer. Therefore, it is widely used in group tuberculosis examinations and pre-school physical examinations.

[0003] Prefilled syringes, also known as prefilled syringes (Prefilled Syringe) or prefilled needles, are new types of drug packaging materials developed in recent years. They are not medical devices, but a component of the drug packaging system. They have two functions: storing drugs and ordinary injections. Prefilled syringes are mainly used for the packaging of high-value products such as vaccines, biological products, biochemical products, antithrombotic drugs, and beauty products. Prefilled syringes refer to a "drug-device-in-one" device that is filled with liquid medicine to facilitate medical staff and patients to inject drugs at any time. There are two main types of prefilled syringes, namely glass prefilled syringes and COP prefilled syringes. The products are mainly divided into two categories: with injection needles and without injection needles. The specifications of glass products are 0.5-10 mL, and the specifications of plastic products are 0.5-50 mL. The prefilled syringe assembly consists of a needle tube, a piston and a push rod. The needle tube consists of a forming tube, a needle (product with a needle), and a protective cap.

[0004] The PPD reagents currently used in the market are all ampoule preparations. In actual use, personnel are required to transfer the reagents from the package to the syringe. First, due to the waste caused by adsorption, a 1ml ampoule can extract a maximum of 8 doses of 0.1ml skin test reagent, and it is inevitable to cause cross-contamination and secondary contamination of drugs. Secondly, under the demand for large-scale screening, due to the complicated preparation work, it causes a huge waste of manpower and time, and even the staff causes harm to themselves during the preparation process. Thirdly, manual infusion by medical staff lacks precise control and cannot be compared with the method of quantitatively filling the liquid with a prefilled syringe.

[0005] During the market research, we learned that the smallest specification of the existing prefilled syringe is 0.2ml, and the specification of the single-dose tuberculin (PPD) prefilled injection is 0.1ml. It is also an urgent problem to develop prefilled syringes with more specifications and types that meet domestic implementation standards.

[0006] Therefore, there is an urgent need for a production process for prefilled single-dose tuberculin injection to solve the above problems. Summary of the invention

[0007] In order to overcome the above-mentioned defects of the prior art, an embodiment of the present invention provides a production process for a prefilled single-dose tuberculin injection. The prefilled single-dose tuberculin (PPD) injection designed by the present invention has the advantages of accurate dosage, convenient direct injection, no pollution, easy transportation and storage, and higher cost performance than the recombinant Mycobacterium tuberculosis fusion protein prefilled single-dose reagent (EC reagent), so as to solve the problems raised in the above-mentioned background technology.

[0008] To achieve the above object, the present invention provides the following technical solution: a production process of a prefilled single-dose tuberculin injection, comprising the following steps: Step 1: Under the condition of Class A laminar flow protection, transfer the commercially available ready-to-use prefilled syringe to the inside of the filling machine, take out the sterile nest box syringe from the outer packaging, and avoid the outer bag from contaminating the nest box and the environment with microorganisms and particles during the entire unpacking process. Before unpacking, the outer packaging needs to be manually cleaned, wiped and disinfected to reduce the particles and microorganisms on the outer packaging bag; Step 2: Remove the inner package in a sterile Class A environment. Since particles may be generated when tearing the film and transferring the liner by vacuum, in order to prevent particles from entering the syringe, avoid excessive movement when tearing the film and transferring the liner, and make full use of laminar airflow to protect the syringe from being contaminated by particles. Perform real-time online particle monitoring in this area to evaluate and control the impact of particles generated during the inner package removal process. Step 3: During the filling process, personnel perform aseptic operations to reduce the interference of personnel operations on the production process. During filling, the filling speed is controlled to ensure the filling accuracy, the filling volume is tested regularly, and the online weighing system is used and calibrated before production; Step 4: During the commissioning and confirmation of the cannula stoppering equipment, the size and roughness of the cannula are checked and confirmed. Because during the stoppering process, the rubber stopper is greatly squeezed and forced out of the cannula, the friction force is very large, so the rubber stopper may be damaged, particles may be generated, and the sealing line may be deformed. It is necessary to reduce the damage to the rubber stopper during the stoppering process and ensure the sealing of the prefilled syringe and the sterility of the product. Step 5: Control the temperature and time during sterilization, and control the pressure difference balance between the inside and outside of the product to sterilize the prefilled needle product; Step 6: Before the light inspection, confirm the illumination of the light inspection machine to make sure it can meet the needs of the light inspection, use defective products to confirm the light inspection machine before use, and then use the light inspection machine to perform light inspection on the pre-filled needle products; Step 7: Label the prefilled needle product after light inspection, and then install it in the card slot of the blister. The placement direction of the syringe needs to be consistent; Step 8: Pack the blisters filled with pre-filled needle products into boxes. Before packing, you need to confirm that the batch number, production date, and expiration date are accurate. Before printing, you need to confirm again that the printed information is complete and accurate.

[0009] Technical effects and advantages of the present invention: The tuberculin (PPD) prefilled single-dose injection designed in the present invention has the advantages of accurate dosage, convenient direct injection, no pollution, easy transportation and storage, and high cost performance compared with the recombinant Mycobacterium tuberculosis fusion protein prefilled single-dose reagent (EC reagent). DETAILED DESCRIPTION

[0010] The technical solutions in the embodiments of the present invention are described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0011] Example 1 The present invention provides a production process of a prefilled single-dose tuberculin injection, comprising the following steps: Step 1: Under the condition of Class A laminar flow protection, transfer the commercially available ready-to-use prefilled syringe to the inside of the filling machine, take out the sterile nest box syringe from the outer packaging, and avoid the outer bag from contaminating the nest box and the environment with microorganisms and particles during the entire unpacking process. Before unpacking, the outer packaging needs to be manually cleaned, wiped and disinfected to reduce the particles and microorganisms on the outer packaging bag; Step 2: Remove the inner package in a sterile Class A environment. Since particles may be generated when tearing the film and transferring the liner by vacuum, in order to prevent particles from entering the syringe, avoid excessive movement when tearing the film and transferring the liner, and make full use of laminar airflow to protect the syringe from being contaminated by particles. Perform real-time online particle monitoring in this area to evaluate and control the impact of particles generated during the inner package removal process. Step 3: During the filling process, personnel perform aseptic operations to reduce the interference of personnel operations on the production process. During filling, the filling speed is controlled to ensure the filling accuracy, the filling volume is tested regularly, and the online weighing system is used and calibrated before production; Step 4: During the commissioning and confirmation of the cannula stoppering equipment, the size and roughness of the cannula are checked and confirmed. Because during the stoppering process, the rubber stopper is greatly squeezed and forced out of the cannula, the friction force is very large, so the rubber stopper may be damaged, particles may be generated, and the sealing line may be deformed. It is necessary to reduce the damage to the rubber stopper during the stoppering process and ensure the sealing of the prefilled syringe and the sterility of the product. Step 5: Control the temperature and time during sterilization, and control the pressure difference balance between the inside and outside of the product to sterilize the prefilled needle product; Step 6: Before the light inspection, confirm the illumination of the light inspection machine to make sure it can meet the needs of the light inspection, use defective products to confirm the light inspection machine before use, and then use the light inspection machine to perform light inspection on the pre-filled needle products; Step 7: Label the prefilled needle product after light inspection, and then install it in the card slot of the blister. The placement direction of the syringe needs to be consistent; Step 8: Pack the blisters filled with pre-filled needle products into boxes. Before packing, you need to confirm that the batch number, production date, and expiration date are accurate. Before printing, you need to confirm again that the printed information is complete and accurate.

[0012] The present invention transfers the commercially available ready-to-use prefilled syringe to the inside of the filling machine under the condition of Class A laminar flow protection, takes out the sterile nest box syringe from the outer package, avoids the contamination of the nest box and the environment with microorganisms and particles by the outer bag during the whole process of removing the outer package, and needs to manually clean, wipe and disinfect the outer package before removing the outer package to reduce the particles and microorganisms on the outer package bag. The inner package is removed under the sterile Class A environment. Since particles may be generated when tearing the film and vacuum transferring the liner, in order to avoid the particles from entering the syringe, the action amplitude is not too large when tearing the film and transferring the liner. Generate particles and make full use of laminar airflow to protect the syringe from particle contamination. Perform real-time online particle monitoring in this area to evaluate and control the impact of particles generated during the unpacking process. During the filling process, personnel perform aseptic operations to reduce the interference of personnel operations on the production process. During filling, control the filling speed to ensure the filling accuracy, regularly check the filling volume, use the online weighing system, and calibrate the online weighing system before production. During the commissioning and confirmation of the sleeve stoppering equipment, check and confirm the size and roughness of the sleeve, because during the stoppering process During the process, the rubber plug is greatly squeezed, and the rubber plug is forced out of the sleeve, and the friction force it is subjected to is very large. Therefore, problems such as rubber plug damage, particle generation and sealing line deformation may occur. Ensure that the damage to the rubber plug is reduced during the plugging process, ensure the sealing of the prefilled syringe and the sterility of the product, control the temperature and time during sterilization, and control the pressure difference balance inside and outside the product to sterilize the prefilled needle product. Before the light inspection, confirm the illumination of the light inspection machine to confirm that it can meet the needs of the light inspection, and use defective products to confirm the light inspection machine before use, and then use the light inspection machine to inspect the prefilled needle product. The products are subjected to light inspection, the prefilled needle products that have passed the light inspection are labeled, and then installed in the card slot of the blister. The placement direction of the syringes needs to be consistent, and the blisters filled with the prefilled needle products are boxed. Before boxing, it is necessary to confirm that the batch number, production date, and expiration date are accurate. Before printing, it is necessary to confirm again that the printed information is complete and accurate. The tuberculin (PPD) prefilled single-dose injection designed by the present invention has the advantages of accurate dosage, convenient direct injection, no pollution, easy transportation and storage, and high cost performance compared with the recombinant Mycobacterium tuberculosis fusion protein prefilled single-dose reagent (EC reagent).

[0013] Finally: The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the protection scope of the present invention.

Claims

1. A production process for a prefilled single-dose tuberculin injection, characterized in that: The following steps are involved: Step 1: Under the condition of Class A laminar flow protection, transfer the commercially available ready-to-use prefilled syringe to the inside of the filling machine, take out the sterile nest box syringe from the outer packaging, and avoid the outer bag from contaminating the nest box and the environment with microorganisms and particles during the entire unpacking process. Before unpacking, the outer packaging needs to be manually cleaned, wiped and disinfected to reduce the particles and microorganisms on the outer packaging bag; Step 2: Remove the inner package in a sterile Class A environment. Since particles may be generated when tearing the film and transferring the liner by vacuum, in order to prevent particles from entering the syringe, avoid excessive movement when tearing the film and transferring the liner, and make full use of laminar airflow to protect the syringe from being contaminated by particles. Perform real-time online particle monitoring in this area to evaluate and control the impact of particles generated during the inner package removal process. Step 3: During the filling process, personnel perform aseptic operations to reduce the interference of personnel operations on the production process. During filling, the filling speed is controlled to ensure the filling accuracy, the filling volume is tested regularly, and the online weighing system is used and calibrated before production; Step 4: During the commissioning and confirmation of the cannula stoppering equipment, the size and roughness of the cannula are checked and confirmed. Because during the stoppering process, the rubber stopper is greatly squeezed and forced out of the cannula, the friction force is very large, so the rubber stopper may be damaged, particles may be generated, and the sealing line may be deformed. It is necessary to reduce the damage to the rubber stopper during the stoppering process and ensure the sealing of the prefilled syringe and the sterility of the product. Step 5: Control the temperature and time during sterilization, and control the pressure difference balance between the inside and outside of the product to sterilize the prefilled needle product; Step 6: Before the light inspection, confirm the illumination of the light inspection machine to make sure it can meet the needs of the light inspection, use defective products to confirm the light inspection machine before use, and then use the light inspection machine to perform light inspection on the pre-filled needle products; Step 7: Label the prefilled needle product after light inspection, and then install it in the card slot of the blister. The placement direction of the syringe needs to be consistent; Step 8: Pack the blisters filled with pre-filled needle products into boxes. Before packing, you need to confirm that the batch number, production date, and expiration date are accurate. Before printing, you need to confirm again that the printed information is complete and accurate.