Existing Production Variances between Pharmaceutical And Chemical Industries
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Author : 李スコット
Update time : 2020-07-28 15:56:29
First, What Are the Similarities?1. The materials for the production of tube packaging are all produced by stamping, using more than 99.97% pure aluminum wafers. The inks are all polyurethane. The use of epoxy resin inner coating materials and rubber tail coatings are similar to industry standards.
2. The specifications for the appearance and the manufacturing dimensions, such as diameter, thickness, thread pitch, softness, hardness, and other aspects, tend to be all the same and are delineated by either the use of metric-based EU standards or the equivalent thereof.
3. The production process is precisely the same, including mixing, stamping, threading, internal spraying, primer coating, printing, capping, tail coating, and boxing.
4. The inspection process for finished-product aluminum tubes from beginning to end all utilize the same manufacturing techniques, such as hardness inspection, length thickness weight inspection, ink colour-fastness inspection, conductivity inspection of primer, and is virtually identical.
5. The general applicable laws and regulations are the same, such as the establishment of fire-fighting facilities, emergency evacuation treatment plans, environmental assessment, the setting of environmental protection equipment, and waste disposal.
What are the noted differences in the manufacture of aluminum tubes for pharmaceuticals? 1. Acceptability standards as dictated by government regulators:
Within the industrial category of pharmaceutical packaging materials/primary and auxiliary packaging, the governmental drug regulatory bureau requires the use of registration numbers. Utilizing the DMF system applies to the production process, inspection standards, production specifications, and supplier information. The information is recorded and updated regularly with finished product subject to regular and irregular flight inspections.
2. The applicable manufacturing management practices differ:
They require pharmaceutical aluminum ointment collapsible aluminum tubes to adhere to GMP operation standards that include following ISO15378 quality management procedures. For general adhesives and the packaging of aluminum tubes, ISO9001 management standards apply.
3. The high standards of production environment specifications.:
The production of the pharmaceutical-grade aluminum tube requires a minimum quantity of at least one hundred thousand units in an IS8 cleanroom for utilizing positive and negative pressure, temperature and humidity, light intensity, and dust count type controls. The number of colonies is set up and managed with the same specifications as the production of various ointment drugs. The packaging of aluminum tubes for the production of adhesives does not require such stringent controls.
4. Evaluation and necessary testing of packaging materials:
Careful assessment of aluminum tube packaging materials selected for different ointments. The ointments are required to ensure the safety and compatibility between the packaging materials and the paste filling material. Therefore, appropriate testing is conducted on these packaging materials before a large amount of filling is containerized. Therefore, avoiding qualitative changes or accidents during the production, storage, and transportation processes, or through the use, and preservation phases, that may lead to possible minor or severe injuries to personnel and patients.
5. Different management awareness and cost structure variances:
Although they are aluminum tubes produced for packaging, they are considered different industries. One is the pharmaceutical packaging industry, and the other is the chemical packaging industry. Therefore, the applicable industry standards are different, and management awareness is different. This difference is vast, and the cost structure of production is likewise, greatly affected.
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