Hardly any pharmaceutical manufacturer can carry on production without packaging, which is a key process for a medicine to enter market. Pharmaceutical Cartoner functions as a replacement of manual cartoning with enhanced efficiency. Although it has been 30 year since the first pharmaceutical Cartoner was made in China, compared with other pharmaceutical equipment, development in Cartoner industry lagged behind at sluggish pace. Despite some impressive progress, the promotion and technology growth in China’s pharmaceutical cartoning equipment still have a long way to go due to many causes. Therefore, both manufacturers and users of pharmaceutical cartoning equipment should inquire its development and growth trend.
1.2 Pharmaceuticals industry application process of China’s Cartoner
At early stage, most medicines in China are packed manually. Progress in production and technology, especially the promotion of machine-made cartons drives application of Cartoner. The first users of Cartoner in China are likely to be the ointment manufacturers in 1970s. In 1960s, Tianjin Lisheng Pharmaceutical Co., Ltd. and Shanghai Sine Pharmaceutical Co Ltd. imported ILME full-automatic Cartoning Machines. Unfortunately, China’s then packaging materials quality and process technique of medicine carton failed to meet the requirements of mechanical packing, the Cartoning Machine could not work properly. In 1980s, pharmaceutical manufacturing saw a rapid development and eye catching growth in manufacturing and quality of machine made cartons. Cartoning Machine are applied in pharmaceuticals industry. Homemade Cartoning Machine started to establish presence in the market previously dominated by imported Cartoning Machine. In addition, except for the Cartoning Machine applicable for cream tubes, that applicable for blistered medicines were put in use in 1990s, when some pharmaceutical enterprise with high output replaced cartoning workers with domestic cartoning machines.
2.2. Requirements for cartoning machine in pharmaceutical industrial application
There are some requirements to be met for cartoning machines in pharmaceutical industrial application. According to Article 4603, GMP compliance standard, the drug wrappage printed with information the same with label content should be managed based on labels. In other words, the outer package and labels of medicines should be managed in the same manner. The requirements for cartoning machine are caused by that of outer package of medicines. Requirement for cartoning machines:
(1) Feed packaging inserts;
(2) Print date of manufacture, batch no., validity, etc.
(3) Count cartons;
(4) Inspect the quality of packaged medicines;
(5) Adapt to change in batch. Not all the requirements are to be met for cartoning machines not specialized for pharmaceutical application.
2.3 Forms & types of cartoning machine
2.3.1 Types of cartoning machine
(1) Cartoning machines can pack either horizontally or vertically. A horizontal cartoning machine pushes contents into a carton horizontally, while a vertical cartoning machine pushes contents into a carton vertically. Currently horizontal machines dominate the market.
(2) The sealing modes of cartons include folding type, pasting type, mixing type, labeling type, extending type, self-locking type, etc.
(3) The shapes of contents to be packed include plate shape, bottle shape, tube shape and irregular shape.
(4) Contents are packed individually, in pairs, in groups and in combination (such as a bottle of antibiotic powder + a bottle of ampoule agent )
2.3.2 Types of cartoning machine
Cartoning machines were used to classified by operation speed, the ones operating at 60-80 cartons/min are classified as medium-low speed type, the ones operating at 80-120 cartons/min, medium-high speed type and the ones operating at speed higher than 150 cartons/min, high speed type. Such classification is determined by the technical levels of 2000 around. Thanks to the progressing manufacture and control technology, cartoning machines boasting speed of 500-600 carton/ min have been off shelf products in global market. In 2009, cartoning machines are to be re-classified. Based on China’s conditions and international standard, the following classifications are recommended: (1) cartoning machines operating at 60-120 cartons/min are classified as medium-low speed type; (2) the ones operating at 150-180 cartons/min are medium-high speed; (3) the ones operating at 200-300 cartons/min are high speed type; and (4) the ones operating at a speed more than 350 cartons/min are extra\high speed type.
The cartoning machines operating at 60-80 cartons/min are structured mainly with cam gears, featuring advantages of compact structure, small size, strong adaptability, cost-effectiveness and convenience and disadvantages of difficult adjustment and low speed; the cartoning machine operating at 80-120 cartons/min are mainly structured with machinery-cam gears, featuring advantages of reliable operation, easy adjustment and extensive applications and disadvantages that the rotary cartoning shaping mechanism cannot adapt to changing speed; the ones operating at 150-200 cartons/min are mainly structured with continuous operating mechanisms, featuring the advantage of high speed and disadvantage of narrow application and particular demand for materials; the ones operating at 280-300 cartons/min are mainly armed with such advanced technology as machinery and servo.
Generally, the cartoning machine operating at 60-120 cartons/min are batch type while the ones operating at 150-200 cartons/min are continuously operating ones.
2.4 Functions of cartoning machines in outer packaging of pharmaceutical end of line
End of line packaging refers to packaging for finished products beyond hygiene zones in modern pharmaceutical industry.
Main equipment in end of line mainly consists of boxing machines, pillow packing machine, thermal shrinkage packaging line, cartoning machines, carton sealing machine, coding machines and packers, armed with such supporting devices as stacking devices, inversion devices, connecting conveyor devices, intermediate handling devices and test control devices. Cartoning machines are the foundation of the complete packaging line and a must for packaging and production of end of line in modern pharmaceutical industry.
3.2 Productivity and conformity hinder the application of cartoning machines made in China
3.2.1 Actual productivity of cartoning machines
Take a cartoning machine made in Shanghai as an example, the model is copied form a product of Nordon, with rated operation speed of 120 cartons/min (max). However, the normal operation only reaches 80 cartons/min. In addition, another cartoning machine of another manufacturer in shanghai is labeled with rated operation speed of 180 cartons/ min (max) and an actual operation speed of 130 cartons/min. The above data reflects the poor production of cartoning machines, both caused by the machine and carton quality.
3.2.2 Percentage of pass of pharmaceutical cartoning machine
According to the criterion, the qualify rate test is double sampling test. Every time, 100 items will be extracted. Firstly, packages are sampled for visual inspection to eliminate the nonconforming product with broken package. Secondly, the products passing visual inspection are sampled to eliminate the products with broken contents, less fed content or omitted content. Pass percentage is calculated based on the sum of nonconforming products, which should not less than 98%.
In fact, 98% percentage of pass is lower than what the manufacturers expected. For a cartoning machine operating at 150 cartons/min, the nonconforming cartons in each shift will reach 1440, which will cost one person/shift to rework, wasting both efforts and cartons. The percentage of pass of manual cartoning is higher than 98% of mechanic cartoning.
3.2.3 Improving the actual productivity and acceptability is a premise of applying a pharmaceutical factory.
Through the analysis above on the actual productivity and acceptability of cartoning machines, we know the responsibility of cartoning machine manufacturers and cartoning factories. The quality of both in recent years is improving, but still cannot meet the expectation of pharmaceutical factory’s owners. The inevitable problem here is the quality of cartoning. If the domestic cartoning machines failed to meet the quality requirement, even the best imported machines will be of no use. According to the known statistics, the foreign cartoning machine takes coarse material while the domestic machine is more available for different cartons.
3.3 The limitation of inner item by the cartoning machine hinders the popularity
According to years of my research about cartoning machine, it is the hardest task for cartoning machine to carton drugs that are small-size in inner package, soft character(e.g. plaster patch), and with complex cartoning of several inner package.
(1) At present, for ointment tube, the cartoning machine can only carton the drugs that are between F16mm~F32mm in tubular specification. Generally speaking, if the specification is lower than F16mm, the cartoning machine cannot work properly. For example, the speed of the cartoning machine is 50~100 cartons/min. And the application range of inner package specification is F13mm~F35mm. However, for the drugs whose specification is F13mm, the speed will be only 50 cartons/min lowered than F13mm, the drugs cannot be cartoned by the cartoning machine, because it is too difficult to aim the paper package when push the small-sized package inserts and the ointment tube together into the carton together, which will also damage the package.
(2)General cartoning machine can only carton hard-character item. When encounter soft-character inter item such as Granular drugs in soft packages or the plaster patches, the cartoning machine will not be able to carton. The good news is that some factories in China are able to produce cartoning machines that can carton soft-character inner bags. Meanwhile, the particularity of soft-character inner item determines that the speed cannot be too fast, which also needs tackling.
(3)Except the package insert, the cartoning machine generally can only carton single inner item. But this cartoning form is far from satisfying the diversification need of modern drug production. Although a few factories have the solutions for various composite cartoning and has successes in it, this type of cartoning machine can only be produced by 3-5 factories.
3.4 The quality issues of domestic cartoning machine
Cartoning machine is classic machinery in packaging machine. Many executive mechanism cannot work without delicate mechanical action. If there are any quality problems in the manufacture, design, assemble and the configuration, the machine will run unstably.
(1) Manufacture quality. In a certain sense, a cartoning machine is the most complicated machinery, for it involves technologies of mechanic, electricity, gas, light, etc. and in the executive process, it requires fine materials. And it is hard for the current pharmaceutical equipment industry, which is of a low overall process level, to produce parts of high precision. The normal manufacturing technology often results in an error accumulation of equipment, errors in performance, a high rate of instability and rejection when the machine is operated at a high speed.
(2) Design quality. The development of cartoning machines in the preceding years is more about imitation by mapping than rational researches on key mechanical configurations. The primitive error of mapping doesn’t relate to a tendency of instability at a low performing speed. When speed accelerates, however, discordance between running gears will result in instability. These reflect the different quality levels of domestic and imported cartoning machines. The solution is to redesign on a theorized base.
(3) Assembly quality. The manual adjustment of adjustable components of cartoning machines is another critical factor that determines the performance of the machine. Technicians of adjustment in the current pharmaceutical equipment industry, however, are not all qualified. The cartoning machine of good design but without a qualified adjustor cannot perform to its best.
(4) Configuration quality. The synchronization and detection control of modern cartoning machines depend on control components of electricity, gas, light, etc. The quality of these components determines the control precision, that is, different configurations will make a great difference in the performance of the machine. By using servo motors or stepping motors of high quality, stability and precision plus advanced and stable servo drive system that integrates sensors, encoders and motors, the actual performance of the machine will far exceed the average.
4 Development of domestic cartoning machines
4.1 Development possibility of domestic cartoning machines in pharmaceutical industry
4.1.1 Draw comparisons between packing by cartoning machines and packing by hand to see cartoning machines’ development feasibility
Compared with traditional manual packing, cartoning machines are at an advantage, which also confirms its development feasibility. Cartoning machines are featured by characteristics like labor intensity, simple operation, high operating efficiency and the like, which meet GMP requirements. Since China joined WTO, she has sped up the pace to be geared to international standards gradually. Pharmaceutical production and requirements put forward that working rate should be increased in the pharmaceutical production field and production cost should be reduced go hand in hand with the operation of cartoning machines.
4.1.2 Development feasibility of cartoning machines in respect of economy
The output of traditional manual packing is 50-60 packages per minute, requiring 4 workers per shift (including specifications folding and lot numbers printing). If the production rate is 120 packages per minute and one more worker is arranged, 9 workers per shift will be required to finish packing.
If domestic cartoning machines are employed in production, take a type of cartoning machine whose production rate is 150 packages per minute (max) and the requirement of production rate being 120 packages per minute, only one worker is required.
Therefore, cartoning machines enjoy a large potential market according to the economy analysis. As far as domestic pharmaceutical cartoning is concerned, adverse situations, like high cost of pharmaceutical cartoning and high labor intensity, can be brought about. In accordance with statistics, the proportion of process cost for pharmaceutical cartoning to the total cost is around 5-6%. Therefore, the cartoning machine is a potential industry. With the development of social productivity, this machine will be more and more valued.
4.1.3 Promotion feasibility of cartoning machines for pharmaceutical industry in respect of downstream industries
The amount of the chemical pharmaceutical factory and the Chinese medicine pharmaceutical factory is more than 5000 while the amount of the animal pharmaceutical factory and the health product manufacturing factory is over 1000 respectively. Of these, the amount of the ointment manufacturing factory is around 300 while the pharmaceutical factory whose medicine is packed in bottle or made into tablets accounts for more than 70%. It can be estimated roughly that the amount of the factory in downstream industries of cartoning machines is over 5500, of which around 1800 factories employ the cartoning machine (estimated). Manual cartoning is still adopted in about 2/3 of domestic pharmaceutical factory. GMP underwent a transformation on a large scale in 1998. Transformation of pharmaceutical factories for the first time was confined to purification and preparations equipments and so forth. Most factories have not yet begun their transformation of drug cartoning. Part of the pharmaceutical factory has basically satisfied conditions required for drug cartoning and production transformation after ten years of endeavor and fund reserving. It can be estimated optimistically that cartoning machines will occupy market shares of around 200-300 in the next few years while the key point is the manufacturer’s positioning, manufacturing, products quality and adaptability .
It seems that the cartoning machine with high-technology, high-quality and high-speed is a potential industry, especially the highlight of time in pharmaceutical industry which comes after GMP transformation, enjoying large potential market and having the ability to march into markets other than pharmaceutical industry, like food, daily chemicals and pigment, etc. At the same time, diversified derivation of cartoning machines and the manufacturing and selling of packing line will be a new trend.
25/7/2013