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The URS stage usually purchases or renovates a water system. The URS (UserRequirementsSpecifications) is first proposed by the user. The URS provides technical basis for the entire system design, construction, commissioning and final acceptance. The supplier will use this file to Design and manufacture, the user uses this document as one of the basis for acceptance.
The risk control points at this stage are as follows:
Risk: The general URS terms, such as the requirements of GMP and FDA, do not have any guiding significance for the design and verification of the system.
Risk control scheme: The proposed URS should follow the SMART principle (S=Specifiable specific, M=Measurable measurable, A=Achievable achievable, R=Realistic reality, T=Time-based time limit).
Bidding and procurement stage risk 1
The contradiction between cost and quality. The quality standard requirements were not fully considered when setting the budget; or the cost was too much to be pursued and the cost was neglected.
Risk control plan: Prepare the URS in the project budget stage, determine the appropriate quality standards, and the project budget is based on this.
Risk 2
The level of water machine and distribution system suppliers, technical level and verification level are low, resulting in poor system quality, verification and project management confusion.
Risk control plan:
Conduct supplier audit work before signing the contract, fully examine the technical background of the supplier, and whether there are well-known cases. It is recommended to conduct on-site audits when necessary, and fully examine the supplier's design capabilities, processing and manufacturing capability verification levels, and project management capabilities to ensure the smooth follow-up of the entire project.
If the user lacks relevant background knowledge, he can also choose the engineering management company to assist in the management of the entire project, which can effectively reduce the risk from design to construction to the acceptance process after the Zui.
The contract payment conditions are clear: a phased payment method is adopted to effectively reduce the economic loss caused to the user due to the low technical level and low credibility of the supplier.
Risk 3
The contents of the contract are vague, such as: the scope of supply, brand, and service content are unclear; the acceptance and payment terms are unclear; the interface between the water machine and the distribution system contract is not clear.
Risk control plan:
In addition to the commercial terms, the contract shall be prepared with detailed technical provisions, with the PI&D and component list as attachments;
Sign the technical terms of service separately, detailing the scope and content of DQ/FAT/SAT/after-sales and other verification services.
The design and DQ phases are generally divided into two parts for full consideration. One is the focus of the user side, and the other is the focus of the supplier.
The risk control points designed by the supplier's design focus include:
Raw water quality and water quality requirements at the point of use. The design should be based on the local source water quality. However, China has a vast territory, and the water quality varies greatly from place to place. The successful scheme for one region may not be suitable in other regions.
Use point water quantity, frequency of use, point of use, water temperature and water pressure requirements. Full consideration of peak water usage, such as CIP water, process water, for system capacity, distribution pump and piping design calculations.
Factory layout, auxiliary facilities, installation and operation constraints to make a reasonable layout design.
The specific design has the following recommendations:
Try to use online TOC and conductance to monitor the operation of the system in real time to reduce the risk of product contamination;
If pasteurization is used, the heat resistance of RO membrane and EDI should be fully considered;
In the selection of process piping, the heat resistance and corrosion resistance of the diaphragm should be fully considered, and the influence of chemical reagents, especially strong acid and alkali, in the process and CIP process should be fully considered;
Pure water system, generally pasteurized, if O3 disinfection is selected, purified water must be used for electrolytic preparation. It is not recommended to use separated air or pure oxygen. It may affect the pure water due to the cleanliness of the air. At the same time, it has been reported in the literature that the electrolysis process will produce certain carcinogens.
The design focus of the user side is to make the layout design of the water system, and reserve sufficient hoisting space/equipment to enter the passage;
Design sufficient load bearing capacity;
Design of utilities such as tap water, chilled water, steam, electricity, compressed air;
Do a good job design period to prevent conflicts and poor connection between water machine and other professional construction, including: civil works, public facilities, water machines and pipelines.
In the DQ stage, the supplier, the user's equipment manager, and the quality in charge of the DQ (DesignQualification Design Confirmation) work may cause the risk that DQ is not taken seriously and DQ is insufficient.
Risk control plan:
Think of DQ as both an audit and a good process for learning the system process for the user.
Approve DQ as one of the conditions for a phased payment.
Design documents and draft DQs should be prepared in advance. At this stage, the supplier is required to provide design documents such as P&ID drawings, component lists, design specifications, and floor plans as confirmation of URS compliance.
FAT (FactoryAcceptanceTest factory is tested)
Risk 1
With water test: For the purified water system, usually many suppliers will choose not to carry water test. If the user chooses to carry water test, the supplier needs to do the cleaning and drying of the RO membrane to avoid unnecessary use in the future. Loss.
Risk 2
FAT is not ready. Generally, suppliers with good reputation will conduct internal pre-FAT. For users, this can make the whole FAT work smoothly, but there are often poor internal FAT organizations, some tests are not carried out, and the documents are not organized. Perfect state.
Risk control plan:
FAT deviation: After the test is over, it is necessary to confirm with the supplier what kind of deviation is resolved before shipping and payment.
Increase the sampling rate: such as I / O test, alarm test and technical data monitoring.
SAT (SiteAcceptanceTest site acceptance test)
Risk 1
Field conditions cannot be used for SAT. For example, the civil works are not completed, the public facilities are not in place, and the pipeline system is not completed. This may cause problems such as contamination of the equipment, discharge of water, and the like.
Risk control plan:
Make sure the civil works are suitable for the installation of the equipment and the SAT.
It is necessary to ensure that all utilities, circulating pipelines (acid passivation using water produced), require reagents to be ready.
Risk 2
Once the equipment is in operation, no downtime will be allowed, otherwise the entire system will need to be disinfected.
Risk 3
Contradiction between water machine and distribution pipeline: the interface is unclear and the linkage is not smooth.
Risk control plan: explicitly required in the contract.
In the IQ (InstallationQualification Installation Confirmation) and OQ (OperationQualification Operation Confirmation) phases, the content tested is basically covered in both FAT and SAT, and will not be described here.
Its advantages is good tear resistance.It is also able to
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Process water is widely used in pharmaceutical production. It is a very important raw material in the pharmaceutical process. It is also an indispensable material in the cleaning process of pharmaceutical equipment. The quality of pharmaceutical process water directly affects the quality of medicines and the safety of medicines. This paper will take the pure water system as an example from the perspective of engineering projects, and briefly explain the quality risk control points of each stage of the new system engineering project.