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Yuchen machinery manufacturing CO.,LTD
Tel:0510-86392118,81603202
Fax:0510-86392080,81603201
E-mail:ycxushu@163.com
Address:Jiangyin city to Xinzhuang Town Industrial Park Road No. 2



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Service plan

1、Warranty service plan
(1)、Product quality Three Guarantees, warranty (quality assurance period) for one year, and provide life-long service parts;
(2)、The first free installation and commissioning, warranty period, due to product quality problems caused by the damage, the supplier is responsible for free repair services.
(3)、The installation and debugging of the purchaser shall notify the supplier in advance for a week, installation debugging sent by the supplier. During installation, the school operator and mechanic co operation and training, until the personnel will be reasonable operation of our products.
(4)、Emergency response: warranty period within user notification, the supplier shall make a clear reply within 24 hours, need maintenance, at the latest within 48 hours sent maintenance personnel rushed to the scene. Under special circumstances, a prototype with the same function can be provided for temporary use by the user.
(5)、Maintenance organization name: Jiangyin Yuchen Machinery Manufacturing Co. Ltd.
Address:NO.2,Zhutangtown,Jiangyin City,Jiangsu Province,China
Tel:0510-86392118,86392007 158526241182
2、Liability for breach of contract
Our solemn promise: the warranty period, due to quality problems and loss of our equipment is not timely maintenance caused, shall I burden on the company, the company has the right to deduct the guarantee money, if necessary, be solved by law. In witness whereof.
3、Other plans
(1)The supplier shall regularly contact the user, understand the use of the device.
(2)Any time, the supplier shall unconditionally accept all kinds of technical advice on equipment users and put forward reasonable suggestions and explanations. After-sales service commitment
1、Product quality Three Guarantees, warranty period of one year, and provide life-long service parts;
2、The first free installation and commissioning, warranty period, due to product quality problems caused by the damage, the supplier is responsible for free repair services. Human factors damage in need of repair, the buyer shall bear the fees accessories.
3、The installation and debugging of the purchaser shall notify the supplier in advance for a week, installation debugging sent by the supplier. During installation, the school operator and mechanic co operation and training, until the personnel will be reasonable operation of our products.
4、The warranty period within user notification, the supplier shall make a clear reply within 24 hours, need maintenance, at the latest within 48 hours sent maintenance personnel rushed to the scene. Under special circumstances, a prototype with the same function can be provided for temporary use by the user.
Letter of indemnity
Our company solemnly promises as follows:
Within the warranty period, our company equipment in the production of quality problems due to the loss of spare parts caused by our company is responsible for the supply and maintenance. As a result of the loss caused by operational errors, the cost borne by the user himself.
GMP verification Guide
1、GMP verification purposes
Objective to verify the GMP pharmaceutical machinery and equipment is to check and evaluate the various links in the selection, design, manufacturing, installation and operation of equipment, to prove that the equipment is in accordance with the requirements of pharmaceutical production, whether meet the equipment safe and effective guarantee function.
2、GMP validation content
GMP verify the contents can be divided into three aspects, namely, design validation, installation qualification and performance verification, the design verification by the manufacturer to verify the installation qualification; manufacturers and users can be verified along, can also separately verify manufacturers; performance by manufacturers and users, also can be performed by the user.
(1)Design validation
The scope of design validation includes: design selection, performance parameter setting, technical documentation, procurement, manufacturing and final inspection:
1)Design selection: with the national policies and regulations to meet the pharmaceutical production, to ensure the quality of drug production capacity, safe, reliable, easy to operate, maintenance and cleaning.
2)Performance parameters: in line with national, industry or enterprise standards, close to and surpass the international advanced level or with the same type of domestic products have obvious technical advantages, rather than repeated development.
3)Technical documentation: technical documents that are complete and in line with national standards.
4)Procurement: according to the technical documents to meet the quality requirements, quality assurance or certification of raw materials and all kinds of materials.
5)Manufacturing: manufacturing, assembly and commissioning of parts according to technical documents, technical documents and related standards.
6)Finished product inspection: according to technical documents, performance parameters and relevant standards for inspection, in line with the conditions of the factory.
(2)Installation confirmation
The scope of installation confirmation includes: equipment installation, auxiliary facilities, air transfer or trial operation, the confirmation of the pharmaceutical production process, etc.:
1)Equipment installation: the adaptability of the equipment in the installation environment, and meet the requirements of drug production, as well as waste, toxic and harmful gases.
2)Auxiliary facilities: auxiliary facilities complete, the connection between each other.
3)Air transfer or commissioning: the stability and degree of adjustment of the function of the machine, the reliability and safety of the instrument.
4)Confirmation of the pharmaceutical production process: to meet the requirements of the pharmaceutical production process and the best condition.
(3)Performance validation
The scope of performance qualification includes: physical production, performance appraisal, operation and maintenance, cleaning, etc.:
1)Physical production: the adaptability and reliability of the equipment in the simulation of production operation or physical production operation.
2) Performance appraisal: the conformity of the equipment to the design parameters in the simulation operation or the physical production operation.
3) Operation and maintenance: equipment operation and maintenance convenience and safety, rationality.
4) Cleaning: equipment cleaning function is complete and operational.
3、GMP verification method
The verification methods of pharmaceutical machinery can be developed according to the different types of equipment to develop the corresponding verification rules, but also divided into three areas, namely, design validation, installation verification and validation of performance verification.
(1)Verification of design validation
1)Check whether the selection of equipment in accordance with current policies and regulations; whether the implementation of GMP pharmaceutical production requirements, and to ensure the quality of drug production; the functional design taking into account whether the purification function and function of cleaning equipment; the operation is safe, reliable and convenient maintenance; whether the use of machine, electricity, instrument integration, microwave and laser infrared technology; whether it has the monitoring function of on-line detection and; of flammable and explosive equipment is considered the safety explosion-proof device effectively; the equipment may occur in the operation of the non normal situation if there is overload, overpressure alarm and protection measures; equipment to meet the interface requirements and production process.
2)Check whether the performance parameters of the equipment are in conformity with the national, industry or enterprise standards; whether the performance parameters are advanced, reasonable, and have obvious technical advantages; the structural design is reasonable, the main performance in the:
a)Contact with the drug design should be smooth, smooth, no edges and corners, grooves, non sticky, non - product, easy to clean;
b)The lubrication sealing device is reasonable and safe, and can not cause pollution to the medicine;
c)There should be effective measures to solve the problems of noise, vibration, heat dissipation and dispersion of the equipment;
d)The selection of raw materials and other components that are in contact with the drug shall comply with the requirements of the nature, purity and quality of the drug;
e)Design from raw materials, packaging materials and finished products and equipment import and export and scrap export should be a clear distinction, not confused;
f)The appearance of the equipment should be beautiful, simple, easy to operate, observe and repair.
3)Technical documentation: if there is a complete, in line with national standards, can guide the production of technical documents. Here refers to the technical drawings, technical data, design qualification documents.
4)Check equipment procurement documents and related raw materials and all kinds of materials, meet the procurement documents and quality requirements. Especially the part of direct contact with the materials, including metal materials and non-metal materials and standard parts, fasteners, should comply with the GMP requirements, if necessary, shall be issued by the material quality assurance or chemical analysis report.
5)Check if the parts are manufactured, assembled and debugged according to the technical documents and relevant standards, and meet the technical requirements.
6)Check the manufacturer's quality inspection department is on the basis of the technical documentation, performance parameters and relevant standards for inspection and comply with the conditions of the factory, which is directly related to the product quality and operation safety take quality veto system.
(2)Verification method for installation qualification
1)Check whether the equipment is suitable for the installation environment, and meet the requirements of pharmaceutical production. "Drug production quality management standards (GMP)" the third chapter provides different types of equipment at the plant level of cleanliness requirements, temperature and relative humidity, ventilation and dust removal requirements, can be appropriate to verify the installation environment according to these requirements, still need to check the equipment used in the discharge of waste, toxic and harmful gases are to meet the requirements of environmental protection.
2)Check auxiliary facilities are complete, can support the normal operation of the equipment, the interface between each other is good.
3)To observe whether smooth operation in idle equipment or test run; there is no abnormal noise and leakage phenomenon; the mechanism of action is coordinated and reliable; can according to the design requirements of regulation and control; instrument work is reliable and safe.
4)Check the equipment manufacturer and user equipment to develop real production performance consultation confirmation scheme can satisfy the design parameters and relevant standards, in accordance with the production process conditions and the optimum operating condition, such as material of the original state, the equipment running speed, the material feeding quantity and the finished product discharging speed, product quality assessment rules etc..
(3)Verification method for performance validation
1)To observe the quality of the physical operation in the process of the equipment simulation production operation or the physical production operation, and verify the adaptability, continuity and reliability of the equipment function.
2)The quality of the finished real operation of equipment inspection, verification of the performance parameters of compliance, such as screen sieving rate; particle size and a flour mill pass rate, particle size and content of fine particle machine; particle content mixed filling machine filling machine; measurement; cleaning machine cleaning quality etc..
3)Check the reliability of equipment safety protection functions, such as automatic rejection, impurity removing, overpressure, overload alarm, stop blocking, no bottle filling stopping, defect warning etc..
4)Check equipment operation and maintenance, inspection equipment operation is convenient and flexible; whether to adapt to people's natural movements; mechanism of disassembly (for variety and cleaning) is convenient; operation safety performance is good; the emergency stop button, whether the safety valve function.
5)Observe the use of equipment cleaning function, check whether the equipment is simple and fast cleaning; cleaning is thorough; whether the other links; leakage.
Yuchen machinery manufacturing CO.,LTD Copyright
Record number:Su ICP 16055187
Hot Tel:400-8815-806
Tel:0510-86006569,86392118
Fax:0510-86392080,81603201
E-mail:ycxushu@163.com
Address:Jiangyin city to Xinzhuang Town Industrial Park Road No. 2
Support:HUSEO
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