Basic requirements for bottling line

- Monday, June 17, 2019

Because different medication may be sensitive to different materials, the packing method is always very important to medications. Compared to other packing methods, there are many advantages of bottling packing which has a long history, and its good sealing, efficient space utilization allows the medication to be with a long shelf life and a low transportation cost. Also, the cost of bottling packing is relatively low, and it is widely used by many manufacturers and plays a dominant role in the packaging market.

Bottling line

Nowadays, bottling line has been well developed, and there are very complete automation solutions for each step, from bottle setting to labeling. The bottling line can greatly increase the packing efficiency, save labor costs and reduce waste of resources. The general principles of all the bottling line are similar, and can be divided into the following sections in accordance to the function:

1. Bottle unscrambler: arrange the scattered bottles in a fixed order and transport them to the conveyor for the next step.

2. Bottle cleaning machine: blow the specially treated high-pressure air is into the bottle to remove dust and foreign matter inside the bottle.

3. Counting machine: automatically count tablets or capsules for filling, according to set parameter.

4. Inserter: automatically insert the required accessories (desiccant, cotton, shock absorption paper, etc.) into the bottle.

5. Capping machine: Put the cap on the filled bottle and then tighten the cap.

6. Induction sealing machine: heat the aluminum foil on the bottle opening to make it adhere to the opening to complete the sealing.

7. Labeler: Stick the label to bottles as request, for distinguishing.

How to choose a suitable bottling line

The bottling packing process generally includes bottle setting, bottle cleaning, counting, inserting, capping, sealing and labeling. There are various solutions for a bottling line and some machines could be removed accordingly, and the bottling speed is depended on the slowest machine of the whole packing line. Therefore, for maximum cost performance, many factors need to be considered.

1. Speed: pharmaceutical factories need to choose the machine according to the output of their own products. It should be noted for many manufacturers, the speed unit of the bottling line is pcs / min, while pharmaceutical factories calculate by bottles. In order to eliminate differences and reduce the error, the unit should be consistent.

2. Function: not all the above functions are necessary for each bottling line. For example, the bottle cleaning and inserting can be removed and that will not affect the running of the bottling line.

3. Quality: Bottling lines of different manufacturers are of different quality, and their features are also different. For example, some bottling lines are suitable for various shaped bottles and for some bottling lines, the counting function is better than others. Also, some bottling lines focus on speed, while for others, the filling accuracy is more important. All the factors will directly affect future productivity.

In addition, the adjustment needs to be simple and efficient when bottle specifications change. It is an important feature of many bottling lines. For instance, for some bottling lines, tools are not needed when adjusting the bottling line for bottles of different specification, and for others, there will be position markers after adjustment, so that the machine could be quickly adjusted next time. And there is a more advanced solution in which all devices are equipped with a programmable logic controller to control the position. So that, when the machines need to change for bottles of another specification, simply needs to input parameters and the machine can be automatically adjusted by the programmable logic controller, it is fast and no manual operation needed during the period, but it's expensive and most manufacturers cannot afford that.

4. User-friendliness: the bottling line is fully automatic, but it still requires at least one person to operate and monitor machines. Hence, the machine needs to adopt the various silent design to make the noise as low as possible. The intelligent degree of the bottling line is also important, the control interface should be simple. The machine shall stop running and remind the monitor, when things go wrong, and the machines shall also remind the monitor, when the packing task is completed or the material is insufficient. Additionally, the bottling line should be easy to assemble. All machines can run separately, and are small in size and can be easily transported and stored.

5. GMP compliant: a qualified bottling line should comply with GMP (Good manufacturing practice) standard, which is described as follows:

  • Manufacturing facilities must maintain a clean and hygienic manufacturing area.
  • Manufacturing facilities must maintain controlled environmental conditions in order to prevent cross-contamination from adulterants and allergens that may render the product unsafe for human consumption or use.
  • Manufacturing processes must be clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
  • Manufacturing processes must be controlled, and any changes to the process must be evaluated. Changes that affect the quality of the drug are validated as necessary.
  • Instructions and procedures must be written in clear and unambiguous language using good documentation practices.
  • Operators must be trained to carry out and document procedures.
  • Records must be made, manually or electronically, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the food or drug was as expected. Deviations must be investigated and documented.
  • Records of manufacture (including distribution) that enable the complete history of a batch to be traced must be retained in a comprehensible and accessible form.
  • Any distribution of products must minimize any risk to their quality.
  • A system must be in place for recalling any batch from sale or supply.
  • Complaints about marketed products must be examined, the causes of quality defects must be investigated, and appropriate measures must be taken with respect to the defective products and to prevent recurrence.

Many of GMP's regulations are ambiguous. Many manufacturers will state " they meet GMP requirements" when they advertise, but the standard for the machine would be different as the different understanding of "GMP". GMP is a principle spirit rather than a rigid test standard. This kind of succinct and beautiful concept needs us to deeply understand needs and content of GMP in all aspects of pharmaceuticals.

The most important thing is that it would be better for users to conduct on-the-spot inspections of manufacturers when purchasing equipment, and inspect their company size, professionalism, and manufacturing management system of the company. iPharMachine welcomes all customers to visit and hopes that our customers could find a satisfactory bottling line.

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