With the rapid development of the era technology, people have put forward higher requirements for the equipment manufacturing industry, especially for the pharmaceutical industry production equipment requirements are particularly high. With regard to the pharmaceutical bottled number packaging production line, which has different technical highlights at different times passed, what are the highlights of the pharmaceutical bottled number packaging line when the pharmaceutical industry entered the GMP era? The author starts with a review of the development of the pharmaceutical bottled number packaging line in China, and combines GMP to illustrate the new points highlighted by the pharmaceutical bottled number packaging line in the post-GMP era. At the same time, the new highlights from the cGMP perspective.
A review of the development of pharmaceutical bottled packaging lines in China
In 2001, the State Drug Administration Drug Administration Office [2001] No. 89 clearly stated that before June 30, 2004, the production of pharmaceutical preparations and APIs in China must all meet the GMP requirements and obtain certification. As a result, people used the border of June 30, 2004, and the subsequent era was called the post-GMP era.
1. Before GMP certification
At that time, the number of bottled bottling equipment used in the production of solid pharmaceuticals by domestic pharmaceutical companies relied mainly on domestically produced single-machine pelletizers or manual operations, and only a few foreign pharmaceutical companies used the entire imported pharmaceutical plastic bottle-packing packaging line.
In 1996, the first pharmaceutical plastic bottled packaging line in China was born in Shanghai Hengyi Factory. Its successful R&D ended the history that there was no pharmaceutical bottled packaging line in China, and it was in Xi'an Lijun Sha Pharmaceutical Factory in Tianjin. Lisheng Pharmaceutical Factory, Shanghai Xinyi Pharmaceutical Factory, Chengdu Kanghong Pharmaceutical Factory and other pharmaceutical companies have been successfully applied. At the time of review, although the entire line used flexible synchronization technology, the equipment was still very simple, there was no speed control, no PLC control, and the production speed was between 20-40 bottles/min.
2. GMP certification
From 2001 to June 2004, China's pharmaceutical companies raised a large-scale GMP certification boom. This period also brought new development opportunities to China's pharmaceutical machinery manufacturing industry. This is a pharmaceutical plastic bottled packaging line The era of "prosperity".
The pharmaceutical glass bottle-packing and packaging line has grown from a few of the original manufacturers to dozens, and the product types are also flourishing. While the local manufacturing plants are springing up, it is worth mentioning that Karma Packing Equipment Co., Ltd., with a high starting point, aimed at the internationally advanced pharmaceutical bottled packaging line manufacturers CREMER and SWIFTPACK products. With the innovative packaging concept, the optoelectronic electronic counting machine was introduced to represent the packaging and packaging lines for bottles, which greatly narrowed the gap between the number of pharmaceutical bottled packaging lines in China and international advanced similar products, and also met some of the domestic high-end customers. Demand.
At this stage, the mechanical pharmaceutical bottled number packaging line of Shanghai Hengyi Company and other manufacturers is also rapidly developing. Not only does it increase the speed to 40 to 100 bottles/min, but also in the degree of automation and equipment reliability, etc. Also have their own bright spots, at this time the mechanical packaging number packaging line has been able to meet the domestic 80% of pharmaceutical companies GMP transformation needs.
At that time, the main point of purchase of equipment by pharmaceutical companies was "whether or not they can pass GMP certification." While the transparency of mechanical pharmaceutical bottled packaging lines is very high, the differentiation between manufacturers is very small, and many users only choose cheap products. It embodies the situation of "a hundred department stores". In the disorderly market competition of that time, Shanghai Hengyi took technical characteristics as the guide and quality as the basic, successively developed functional products with multiple chain detection and control represented by missing grain detection technology and won many awards. The favor of domestic pharmaceutical companies was that approximately 500 Hyundai pharmaceutical bottles were used in approximately 500 companies.
3. Post GMP era
From July 2004, it is known as the post-GMP era. The pharmaceutical machine market saw a "cold stream." At this point, the pharmaceutical companies' ideas for equipment procurement are shifting from low prices to refinement, quality and technology. From the statistical data of Shanghai Hengyi Company in 2006, most users chose to purchase the electronic number of bottle packaging lines, and their sales performance accounted for 80% of the annual sales, and the speed of the packaging line In the high speed (80 ~ 120 bottles / min) mainly; At the same time, many users of the purchase of template mechanical grain machines are also equipped with an online detection device. It can be said that at this time, the user's requirements for the pharmaceutical bottled several-packaging line have changed from the previous GMP certification to a true increase in the yield and packaging quality. This is also the highlight of the pharmaceutical bottled number packaging line in the post-GMP era. Highlights.
New Aspects of Pharmaceutical Bottled Packaging Lines in Post-GMP Era
With the end of the large-scale GMP certification, some pharmaceutical companies have been eliminated and the other partially winning pharmaceutical companies are faced with a situation in which the output is expanded and the benefits are increased. They need to purchase new equipment. At this time, our country's pharmaceutical companies have become more calm and rational, and they will put forward higher requirements for new equipment. The pharmaceutical bottled packaging line as part of the pharmaceutical machine, its highlights in the post-GMP era, can be explained from the following three levels.
1. Drug safety
Broadly speaking, after the drug is packaged and packaged, the drug must meet the following requirements within the shelf life of shipment, storage, and delivery to the user: the dose, chemical composition, and biological activity should be kept constant to prevent misuse and adjustment. At the same time, the process can be traced and clarified. These requirements will promote the emergence of new technical points in pharmaceutical bottled packaging lines.
â– Safety measures for drug packaging
In order to reflect the principle of safety of pharmaceutical packaging, there are three aspects involved in pharmaceutical bottled packaging lines:
Scientific design of plastic bottle packaging. Such as the use of cork paper, plug PE film, plug cotton and other methods to prevent vibration and produce debris; such as the use of antioxidants, desiccants and other methods to prevent deterioration, mildew or reduce drug prices; such as the use of aluminum foil seal design To meet the sealing requirements.
The safe and effective design of drug packaging materials. The application of high barrier materials, such as PE, PP, PET, etc.; the shape characteristics of the plastic bottle design must be scientific and productive, such as the shape of the shape and the design of the bottle mouth; the requirements of aluminum foil, need to have Partition, adhesive and bottle mouth affinity.
Ensure the safety design of the production process. Through the effective monitoring and control of all aspects of the equipment during the operation of the entire pharmaceutical bottled-numbered packaging line, it is ensured that each bottle of drug packaging process is safe, and that there are no defective drugs. For the safety control of pharmaceutical bottled several-packaging line, it should be carried through in various aspects such as sterilizing bottles, air cleaning, stopper desiccant or plug cotton, screw cap, aluminum foil sealing, labeling, and batching.
â– Key points quality testing items for medicinal bottled packaging lines:
(1) automatic bottle unscrambler process, sample bottle testing;
(2) The number of grain processing steps, lack of grain detection (or put into the post-automatic detection), the recent domestic breakthrough in the detection of broken particles;
(3) Inserting machine process, such as paper jam detection, and if the plug desiccant leak detection and anti-broken bag detection, and then plug cotton plug leak detection;
(4) Capping machine process, such as without cover, reverse cap and oblique cap detection;
(5) Aluminum foil sealing machine process, Shanghai Hengyi has successfully developed online airtightness testing, which will replace the situation of most domestic pharmaceutical companies relying on laboratory spot checks;
(6) The process of labeling machine is currently testing for missing label and missing code. In the future, it will develop in the direction of diagonal labeling and marking.
(7) The process of cartoning machine, leaking instructions, leaking bottle, bad box and missing lot number.
These online testing measures can greatly increase the safety of pharmaceutical packaging. At present, the gap between China's pharmaceutical machinery and foreign countries in terms of mechanical performance is very small, but there are still many gaps in online testing.
2. Efficient equipment
Efficiency is also an important indicator for evaluating the true efficiency of a device. From the current market actual situation analysis, pharmaceutical companies to buy medium and high-speed equipment, especially 80 ~ 100 bottles / minute range of drug machine. At present, the overall level of domestic equipment manufacturing, in this speed range, the domestic choice of equipment is more, and the technology is also more mature, complete sets, the cost is relatively high. Therefore, pharmaceutical companies may decide on the actual production process. It is worth mentioning that the quantity of each pellet of the pelletizer should be considered.
â– It is convenient and quick to change the specifications of the products.
This is an important aspect of testing whether the pharmaceutical bottled several-pack line is efficient. for example:
(1) Line A speed is 100 bottles/minute, each shift is 7 hours (420 minutes), 3 hours (180 minutes) are required for replacement of specifications, and 240 minutes is left for production, ie 240 points x 100 bottles/minute = 24,000 bottle;
(2) Line B speed is 60 bottles/minute, replacement specifications take half an hour (30 minutes), and 390 minutes remain for production, ie 390 minutes x 60 bottles/minute = 23,000 bottles.
This example shows how important the time taken by replacement specifications is for the entire line capacity; at the same time, blindly pursuing high speeds is insignificant.
For manufacturers, to achieve the goal of simple and quick, in the whole line of pharmaceutical bottled line design, it is necessary to avoid replacing parts as much as possible, change the “exchange†to “adjustâ€. At the same time, it must also be considered that the adjustment range of the equipment should be as large as possible to accommodate various specifications of the bottle. Such as Shanghai Hengyi's products, for 50ml ~ 300ml specifications of the bottle, only need to be adjusted to replace the specifications, the operation is simple, reducing the maintenance workload, but also save labor costs for the pharmaceutical factory.
â– Easy to clean.
The pharmaceutical bottled number packaging line should be easy to clean and disinfect, as well as to facilitate the removal of previous batches of remnants. This is an important principle of GMP. Because the batch number must be completely cleaned and disinfected. For the equipment, it is unavoidable to dismantle and clean certain units. This requires that during the entire line design, the parts that need to be disassembled and cleaned must be simple and lightweight, and the tool-free installation should be implemented as much as possible. Avoid using special tools.
â– Good stability, reliability and composability.
When designing a pharmaceutical bottled number packaging line, the fastening of the mechanical structure should be considered as much as possible. The fastening form of the component should be reasonable and reliable, not easy to loosen, and the transmission part must have safety protection measures. Instead of advancing the means of increasing the speed of machinery to increase production capacity, it is necessary to increase the number of stations to avoid premature failure of machinery due to high speed and high temperature.
In addition, pharmaceutical glass bottle packaging lines should reflect the flexible combination of stand-alone to be able to independently control the operation, the combination of natural lines to be able to link, to achieve flexible synchronization.
â– Humane operation.
The humanized operation of pharmaceutical bottled several-pack packaging line makes the operator feel convenient, comfortable and less prone to fatigue. In order to reflect the care of workers and improve the working environment of workers, the operating noise of pharmaceutical bottled packaging lines should be as small as possible, and the number of machines should have a vacuum cleaner interface to avoid the damage caused by the particles flying as far as possible. At the same time, the control operation is easy to understand and can effectively prevent misoperation.
â– Perfect after-sales service.
Manufacturers of pharmaceutical bottled-number packaging lines should provide high-quality after-sales service for pharmaceutical companies, as well as supply training for operational training, spare parts, or replacement parts. They must also be able to assist users in making DQ, IQ, OQ, PQ, etc. verification. Technical support documentation should describe in detail the functionality, performance, parameters, and operating instructions of the equipment, as well as a list of equipment installation drawings, electrical schematics, parts, or replacement parts.
3. Produce low-cost integration
(1) The principle of matching with the production scale, determine the speed of medicinal bottled line according to the batch quantity of each lot and the characteristics of the company's production process.
(2) The principle of cost-effectiveness: First, the safety of pharmaceutical packaging, that is, to avoid complaints, reduce crises and losses, and improve the quality of qualified rate; second, high efficiency and high output to create profits.
(3) The principle of space saving ensures that the equipment is small in size and takes up less clean areas to reduce operating costs.
(4) The principle of energy conservation, considering the low energy consumption of equipment and low consumption of drug packaging materials.
(5) Reduce the principle of employment, consider the degree of automation of equipment to reduce labor.
Outlook
With the introduction of the new GMP version in China, it will continue to be integrated with cGMP, and the following new bright spots will emerge in the pharmaceutical glass bottle packaging line:
(1) The operation has regulations, the operation has monitoring, the process has records, and there is a summary afterwards;
(2) Property confirmation will be continuously improved and will be developed around DQ, IQ, OQ, and PQ;
(3) Challenging tests of equipment, the variable indicators determined within certain limits are guaranteed to be achieved;
(4) Change control of equipment will be developed in the direction of change → orderly → assessment → reconfirmation and revalidation;
(5) Consider the two processes of deviation investigation and parameter release;
(6) Further improve and improve the cleaning and disinfection of equipment;
(7) Strengthen the authorization of PLC data input, focus on electronic records and electronic signatures, and focus on remote control and adjustment.
In short, the general idea of ​​the future development of pharmaceutical glass bottle packaging lines in China is traceability and clarification.
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