Recently, reports of domestic and foreign companies being warned, recalled and even punished for finding visible foreign bodies in spot checks of injections have appeared in the news.
So, what is a "visible foreign body"?
Chinese Pharmacopoeia CHP-0904 defines visible impurities in drugs due to imperfect production process or abnormal events as visible foreign bodies, and introduces relevant detection methods and regulations on the number of visible foreign bodies. Specifically, visible foreign bodies are insoluble substances that can be visually observed under specified conditions in injectable substances, ocular liquid mechanisms and sterile apis, with a particle size or length usually greater than 50μm.
The presence of visible foreign particles in drugs can affect the quality of the drug solution, the application and marketing of the product, and the effectiveness and safety of the drug.
It can be seen that the influencing factors of foreign bodies include raw and auxiliary materials, packaging materials, quality control of ampoule cleaning, quality control of ampoule sterilization, quality control of material and liquid sterilization, quality control of filling process, production environment control, personnel control and lamp inspection process control.
The production environment control includes air purification system, environmental cleaning effect and clean clothing. The fabric, style, wearing and cleaning method of clean clothing will have an impact on visible foreign bodies. In this paper, we focus on the fabric of clean clothing.
As a professional provider of protective wear equipment in the pharmaceutical industry, Capelliton is committed to providing customers with quality products.
Capelliton's clean clothing fabric is made of special polyester filament and conductive fiber through a special process. Can be used for about 100 times, with cleanliness, comfort, barrier, resistance to humidity and heat sterilization and durability, anti-static and wearing soft and comfortable characteristics.
Its main advantages are as follows:
1. Cleanliness:

The fabric of ordinary clean clothing is easy to dust and drop fibers, and it is easy to have many threads, tie wires at the splicing place, and jump wires. Gabor clean clothing fabric selection of high quality filament fiber, no dust, no dust, no fiber. Excellent workmanship, sewing to reduce sewing lines or edge treatment or tight outsourcing clean fabric and other details, as far as possible to reduce dust. After the garment is finished, the thread shall be treated by three processes: cutting, burning and hot drying to ensure maximum compliance with the cleanliness requirements. At the same time, it can provide the dust detection report of professional organizations.
2. Barrier:
The barrier rate of ordinary clean clothes is generally about 40%, and the barrier rate of Garb clean clothes is 90.3% (see cleaning and sterilization verification procedures). The fabric is exquisite and the dust penetration rate is low. It can effectively block particles with particle size above 0.5 micron, effectively control the pollution of the human body to the clean environment, and also prevent the harm of harmful substances in the environment to the human body.
3. Anti-static property:
Made of high quality raw and auxiliary materials, it has good anti-static property, fast dissipation of static electricity during operation, and effective control of dust adhesion, so as to protect the quality and safety of products; In addition, the AC power can prevent personal injury.
4. Durability:
The durability of clean clothes is not only conducive to reducing the replacement frequency of clean clothes, reducing the production cost, but more importantly, it can prevent the failure of clean clothes within the service life and the harm caused to the production.
Gabor clean fabric is made of high quality filament fiber, which has excellent tensile and aging resistance. It can be used for about 100 times under the condition of 121°C humid heat sterilization. Conventional clean clothes will harden, deform and even be damaged after being sterilized for 20-30 times.
5. Safety and comfort:
In addition to considering its barrier performance, clean clothes should also have both comfort, otherwise it will produce a stuffy feeling. The raw materials selected by Gabor clean clothes are all high quality raw materials, and some main materials are imported pharmaceutical grade raw materials, and through special treatment, to meet the requirements of pharmaceutical grade certification, and wear comfortable and breathable.
The quality of medicine is related to life and health, in the process of production, every link should not allow a trace of negligence. Capelliton always takes the protection of personal safety as its responsibility and mission, pays attention to quality, strives for perfection, does a good job in every detail, and provides users with valuable products and services.