On Quality Management of Packaging and Printing--The Voice of God (1)

The Fifth God's Voice - End Users Talk about Quality

In the packaging supply chain, end-users and packaging and printing companies rely on each other, and pharmaceuticals, cold drinks, cosmetics, and camera equipment are major customers of packaging and printing companies. How can customers be favored? How to retain the customer's order? What specific requirements do end-users have for packaging printing quality? I hope this article will inspire you.

Pharmaceutical companies - AstraZeneca

AstraZeneca's pharmaceutical packaging is based on blister packs. Currently, there are six blister packaging lines. In 2004, the company produced blister-packed drugs that accounted for 95:6 or more of locally produced drugs. Other packaging formats include easy-to-push packaging. , Easy to tear double aluminum blister packaging and blister packaging and flexible packaging combination packaging.

1. Quality requirements for pharmaceutical packaging materials

At present, the printing and packaging materials used for the packaging of medicines are aluminum foil, (paper-plastic, aluminum-plastic) composite film, paper for printing labels and instructions, and cardboard for production carton. According to whether the packaging materials and the drugs are in direct contact, the quality requirements for the materials are also different. For aluminum foil, composite film and other internal packaging materials, the safety and sanitation of the material itself is the primary consideration. The material composition should not contain harmful substances, no toxic additives, and no impurities, no reaction or adsorption with the contained drug, etc. The problem of cabinet solubility, printing ink can not be in direct contact with the drug. The amount of residual solvent in the adhesive is within a limited range, and there is no odor in the heat seal layer. Insects, hair, adhesives, dirt, material debris, etc. are strictly prohibited, and the inner packaging material is required to have a certain resistance; medium-strike, pressure-resistant, tensile-resistant, and rupture-resistant mechanical strength, etc. to provide basic protection for medicines. Features. In addition, according to the specific requirements of drugs, the inner packaging material itself should also have good barrier properties such as moisture-proof, oxygen-barrier, gas-barrier, shading, and fragrance-preserving, and have good high temperature resistance, light resistance, cold resistance, chemical resistance, etc. Anti-aging and other stability, to ensure the quality of drugs within the validity period.

The quality of some packaging materials can not be judged correctly according to sampling conditions during acceptance. For example, aluminum foils, composite films, labels, etc., which are packaged in a coiling manner, can only be inspected at the beginning of the sample volume during acceptance and cannot be sampled. , so the test has great limitations.

Different packaging methods have different quality requirements for pharmaceutical packaging materials. Materials used for fully automatic packaging are much more demanding than hand-packed materials, especially the adaptability of materials, such as the die-cutting quality and labelling rate of labels, specification size deviations, sockets and locks of paper boxes, etc. All have higher requirements. These on-machine adaptive control indicators cannot be fully verified by incoming materials inspection.

2. Quality requirements for printing companies

On this issue, Mr. Qin Rongxing, the head of AstraZeneca's Quality Assurance Department, believes that suppliers should carefully manage items related to printing, and that the electronic documents and films passed to the printers and the printer's own print versions must be managed safely.

Different drugs, such as two different doses of drugs, drugs with irrelevant or completely opposite pharmaceutical mechanisms, if the packaging is confused in the printing process, the consequences can be disastrous, and therefore there must be a sound system of management. The printed version that has been destroyed must have an accurate record, and the old version must not be mixed into the updated version.

Printing equipment to ensure health, in particular, there must be strict restrictions on the amount of dust. If there is a black spot on the plate, the original drug packaging requirement may be 50 mg, and there is a black spot between 5 and 0, which becomes 5.0 mg. In addition, information errors or unclear printing are also to be avoided. In addition to meeting the quality requirements of conventional prints, the acceptance of the printing and packaging quality of pharmaceutical packaging is also relatively strict with respect to the requirements for color shift and overlay accuracy control.

In addition, the dimensional deviation requirement of the specification is less than ±0.5 mm. The accuracy of aluminum foil and composite film marking with photoelectric tracking mark is 1%. , There are restrictions on the size of the paper box and the stability of the quality of the paste box, and the accuracy of the number of labels and labels on the machine.

3. Five elements of integrated quality management

In principle, the same batch of products is best done by the same group of people. Because the operator has been replaced, it is uncertain whether the process will follow the original process.

(2) Equipment

Not replaced. After the production runs normally, the same batch of products is preferably completed on the same production line. Part of the printing is not allowed to be printed on this piece of equipment, and part of it is changed to another piece of equipment. The relative stability of the equipment or the production line is required to be guaranteed. At the same time, the printing plant will also reserve a reserve production line. When there are problems with the main production line and the production line cannot be resumed in time, the reserve production line will begin to operate. However, this situation is rare and it is not expected to happen. Because the replacement is easy to make print quality differences, causing consumer doubts.

(3) Materials

AstraZeneca will use packaging materials for its brands (brands and specifications), such as printing plates and inks that are not frequently replaced.

(4) Method

It mainly includes production process methods and product quality inspection methods. The process must be verified by both parties and it must be fixed once it is determined. If there are changes affecting product quality, users must be notified. If it does not affect the quality of the product and it only changes slightly, it can be implemented after the printing company has evaluated and verified it.

(5) Production environment

Pharmaceutical packaging materials have special requirements on the environment, especially in the dry or wet conditions, which will cause the product quality to decline. Therefore, specific analysis should be conducted on specific conditions.

4. Select suppliers

AstraZeneca usually chooses two companies, one as the first supplier and one as a backup. The principle is to choose the right one. The best company is not necessarily the best one because some medicines may be small in volume. Based on price factors, choosing the best supplier is not suitable.

5. AstraZeneca's recommendations for quality work

Domestic printing companies pay more attention to the problems of color difference and color shift. However, the influence of the stability of the post-press processing on the quality of finished products should also be an aspect that printing companies actively pay attention to, but at present, they are easily overlooked by general printing companies. AstraZeneca advises printing companies to further enhance quality management in print version management and carton processing accuracy.

(to be continued)