Foreword

Some insiders predict that the demand for international pharmaceutical packaging is increasing at an average annual rate of 6.3%, which means that the total amount in 2009 may exceed 30 billion US dollars, which is easy for a huge market. With the rapid development of the social economy, the pharmaceutical packaging industry has become more and more mature. The diversification of medicine types also brings diversification to the form of pharmaceutical packaging and accelerates the development of the pharmaceutical packaging industry. Medical packaging is the packaging of special commodities. After the medicine is processed and formed, it plays an important role in protecting the safety and effectiveness of the medicine, facilitating transportation, storage, sales and use. Because the medicine packaging material is used for packaging special commodities-medicines, it belongs to the category of special packaging and has all the attributes and uniqueness of packaging.

However, compared with foreign countries, China's production level of pharmaceutical packaging materials is clearly still at the initial stage: lack of accuracy of drug dosage, lack of children's packaging; drug packaging is rough, not easy to access; lack of packaging for poison, hemp, and psychotropic drugs Safety; The minimum packaging of medicines is too large, which is not suitable for the needs of clinical use. Hospitals often have to unpack and divide the inner packaging before use. The common problems, which make the overall value of medicines greatly reduced.

Some experts pointed out that the current 65% of China's pharmaceutical packaging level still lags behind the world average in the 1980s. The quality of packaging materials is very low, and its contribution to the pharmaceutical industry is also very weak. In developed countries, packaging accounts for 30% of the value of drugs, while in China, this value is 10% lower. In addition, there are still some outstanding problems, such as the need to improve the compatibility of new pharmaceutical preparations and new packaging materials in China. The huge gap between the two makes this industry likely to become the most promising growth point for China's pharmaceutical economy in the next few years.

Classification of medicine packaging materials

According to the way of use: According to the way of use, pharmaceutical packaging materials are divided into direct use (such as solid medical polyolefin plastic bottles, etc.), need to be cleaned before use (such as ampoules, etc.), indirect use or indirect contact with drugs (such as medical glass tubes) , Aluminum caps for antibiotic bottles, etc.).

According to the material composition:
(1) Plastic (thermoplastic, thermosetting polymerized material);
(2) Rubber (thermosetting polymer compound);
(3) Glass (commonly used silica);
(4) Metal (usually aluminum);
(5) Composite (aluminum-plastic combined cover, composite film for drug packaging);

Divided by shape: medicine packaging materials are divided into containers (plastic containers for eye drops, etc.), tablets / bags (medicinal PVC hard tablets, compound bags for pharmaceutical packaging, etc.), plugs (butyl rubber infusion bottle stoppers) Etc.), lid (oral bottle tear aluminum cap, etc.) etc.

Quality requirements for pharmaceutical packaging materials

In order to confirm that the pharmaceutical packaging materials can be used for packaging medicines, it is necessary to monitor the quality of these materials departments. According to the particularity of the use of the pharmaceutical packaging materials, these materials should have the following characteristics; can protect the pharmaceuticals from the environment during storage and use The effect of maintaining the original properties of the medicine: the nature of the medicine packaging material during storage and use should have certain stability; when the medicine packaging material wraps the medicine, it cannot pollute the production environment of the medicine; the medicine packaging material must not be carried during the use process Substances that can't be eliminated that have an effect on the packaged drugs; the drug packaging materials and the packaged drugs must not react chemically or biologically. Therefore, the quality standards of pharmaceutical packaging materials need to prove that the materials have the above characteristics and are effectively controlled. At present, the quality standards of pharmaceutical packaging materials at home and abroad are similar to those of several systems.

(1) Pharmacopoeia system; Pharmacopoeia appendices of developed countries all list the technical requirements for pharmaceutical packaging materials (mainly for materials).
(2) ISO system; formulate standards according to shape (aluminum cap, glass infusion bottle).
(3) The industrial standard system of various countries; it has gradually transformed into ISO standard.
(4) Domestic pharmaceutical packaging material standard system; the form is the same as the IS0 standard, and the safety items are slightly less than the advanced national pharmacopoeia.

At present, the domestic and international quality standard systems for pharmaceutical packaging materials are as follows.

Foreign pharmacopoeia: (1) safety items; abnormal toxicity, hemolysis, cytotoxicity, chemical eluates, arsenic in glass products, vinyl chloride in polyvinyl chloride, additives in plastics, etc .; (2) effectiveness items; Confirmation of materials, water vapor penetration (overflow), tightness, and torque.

ISO standard; basically involves all the characteristics of pharmaceutical packaging materials, but lacks material confirmation items, and also lacks other substances (bacteria counts) that cannot be eliminated during use and the required quality level for supervision and random inspection.

Domestic standards; the current main items and formats are similar to ISO standards, and some technical parameters are slightly inferior. There are also safety-related items such as "microbial count" and "abnormal toxicity".

Quality standards for pharmaceutical packaging materials

According to the characteristics of pharmaceutical packaging materials, the standard of pharmaceutical packaging materials should include the following items:

(1) Confirmation (identification) of materials; mainly confirm the characteristics of materials. This is because special inspection items need to be set according to different materials. For example, polyvinyl chloride materials should be checked for oxyethylene monomers, and polyethylene terephthalate (PET) materials should be checked for acetaldehyde residues. The second is to prevent doping. In addition, the user must be able to confirm the consistency of the source of the material.

(2) Inspection items of materials and containers

Check the chemical properties of the material: first check the amount of material leached in various solvents, mainly check harmful substances, low molecular weight substances, unreacted substances, substances brought into the production, additives, etc. Commonly used solvents are water, ethanol and n-hexane. Common test items include reducing substances, heavy metals, evaporation residues, PH value, ultraviolet absorption, etc. Then check the specific substances in the material, such as the amount of vinyl chloride monomer in the PVC hard film, the amount of catalyst in the polypropylene infusion bottle, and the amount of residual solvent in the composites section. Finally, check the amount of additives added during material processing, such as sulfide in rubber, plasticizer in PVC film (dioctyl phthalate), and antioxidant in polypropylene infusion bottle.

Check the performance of the material and container: the container needs to check the tightness, water vapor transmission rate, drop resistance, and dripping amount (if the container has a quantitative function); the sheet material needs to check the water vapor transmission rate, tensile strength, elongation ; If the material and container need to be used in combination, the heat seal strength, torsion force, and the size of the combined parts should be checked.

(3) Biological safety inspection items of materials and containers

Number of microorganisms: Determine the amount of various types of microorganisms according to the dosage form of the material and container.

Safety: According to the materials and the dosage form used by the container, items such as abnormal toxicity, hemolytic cell toxicity, eye irritation, bacterial endotoxin, etc. must be selected for testing.

The blind spot of medicine packaging materials supervision

Medicine packaging materials are packaging materials and containers that come into direct contact with medicines. The quality of the pharmaceutical packaging material has a great influence on the quality of the drug. Because the pharmaceutical packaging material may bring bacteria and other microorganisms, some harmful substances in the packaging material may be dissolved out by the drug, resulting in drug contamination; at the same time, some ingredients in the drug may be in During packaging storage, it is absorbed by the packaging material or reacts with the packaging material, which directly affects the quality of the drug or the dosage of the drug.

At present, an important issue of pharmaceutical packaging that is currently receiving great attention is how to reduce accidents caused by children's exposure to drugs or misuse of drugs. Statistics show that 30% of the deaths of leopard children in many countries are due to the misuse of drugs. Some governments have more legislation to regulate all blister-packed drugs, because the packaging of these drugs is similar to the packaging of many candy. However, compared with the quality management of medicines in China, the quality management of pharmaceutical packaging materials is currently lagging significantly, and even a "blind spot" of supervision has appeared.

Existing problems: mainly concentrated in the following aspects.

(1) The overall quality of the personnel of the pharmaceutical packaging material production enterprises is not high, especially the quality and ability of the inspection personnel is not high;
(2) The hardware facilities are imperfect, and the testing equipment cannot keep up with the requirements;
(3) Production quality management is not standardized.

Regulatory measures discussion

(1) Improve the laws and regulations supporting the supervision and management of pharmaceutical packaging materials: It is recommended to formulate more operational supervision and management methods for the supervision of the production and use of pharmaceutical packaging materials, so that the daily supervision is scientific, standardized and procedural to promote the quality of enterprises Improvement of management level.

(2) A GMP certification system for pharmaceutical packaging material production enterprises is issued as soon as possible: It is recommended that pharmaceutical packaging material production enterprises also be subject to GMP certification to ensure the quality of pharmaceutical packaging materials from the source. The implementation of GMP certification for pharmaceutical packaging materials enterprises will promote the normal competition and healthy development of the pharmaceutical packaging materials industry.

(3) Strengthen the construction of testing institutions and testing capacity: it is recommended that the Municipal Institute of Pharmaceutical Inspection improve the testing of pharmaceutical packaging materials, such as the physical testing of pharmaceutical packaging materials. It not only meets the regulatory requirements, but also solves the problem that the pharmaceutical packaging materials cannot be fully inspected in one area, and can also share resources in one area. Enterprises are required to strengthen the provision of general testing instruments and strengthen testing capabilities. For testing items that cannot be done under limited conditions, such as infrared and abnormal toxicity tests, a pharmaceutical packaging material testing agency can be entrusted to test. Units that use pharmaceutical packaging materials should also specify the inspection items that must be done, and check the quality of pharmaceutical packaging materials.

(4) Increase training efforts: In view of the current weak technical strength of professional quality management personnel and inspection personnel of pharmaceutical packaging materials enterprises, it is hoped that the National Bureau and the Provincial Bureau can compile books on the knowledge of pharmaceutical packaging materials and organize training and learning to strengthen pharmaceutical packaging The training of knowledge on materials standards, inspection, compatibility testing of pharmaceutical packaging materials and drugs, etc., improve the quality awareness, standard awareness and testing level of pharmaceutical packaging materials enterprises. At the same time, it is required that the quality management and inspection personnel of pharmaceutical packaging materials must reach the corresponding professional and technical capabilities and implement the post access system.

summary

In order to strengthen the management of pharmaceutical packaging materials and containers, the State Drug Administration passed and promulgated the "Administrative Measures on Packaging Materials and Containers for Direct Contact with Drugs" on June 18, 2004, which clarified the types of pharmaceutical packaging materials that are subject to registration management And conduct spot checks on the production and distribution of pharmaceutical packaging materials. However, compared with the strict GMP management of pharmaceutical production, packaging materials companies also appear to be more relaxed. The above suggestions are only a family statement. If it can be helpful to domestic drug packaging supervision, the author believes that it will be a lot of progress for the entire industry.

Room Divider

A room divider is a screen or piece of furniture placed in a way that divides a room into separate areas.

Room dividers are used by interior designers and architects as means to divide space into separate distinct areas.

A room divider for a conference hall.
There are a number of different types of room dividers such as cubicle partitions, pipe and drape screens, shoji screens, and walls. Room dividers can be made from many materials, including wood, fabric, plexiglass, framed cotton canvas, pleated fabric or mirrors. Plants, shelves or railings might also be used as dividers. Portable room dividers have folded wall panels supported on wheels.

Types

In general, room dividers are used in one of these ways:

To divide rooms, creating a more efficient use of the space within the room.
As decorators and/or accent pieces to add character to room space.
To hide areas of different usage or privacy protection
To decorate rooms for better home design effect
Room dividers differ in nature being either:

Permanent as in using wine shelves in restaurants
Built in as in sliding partitions in offices
Portable or temporary as for example in convention centers
Fixed room dividers and hanging room dividers
They may completely obscure as in floor to ceiling dividers, or may allow sight through as for example when plant pots are used to divide areas.

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