As the elapse of time, the otherness of medical apparatus and instruments and complexity may be increased, relevant design risk and the challenge sex in production process also can increase subsequently. The manufacturer of existing product must find first-rate to produce kind in order to achieve higher manufacturing reliability and efficiency. The manufacturer of new product must produce technological process and layout to make to what did not come set beforehand. Producing technological process is to be in normally " products plan phase " be defined. In above in two kinds of circumstances, superintendency branch can insist ask production makes a system want to accord with corresponding standard not only, and should build the base that produces flow in sufficient understanding. Current, the computer is auxiliary note model build a model to had been applied extensively in product design. But the manufacturing technology imitate of this kind of goods still is used lesser. From product and mould design, and the property performance of the system that note model, optimize to plant site all the time, system and integrated ground use simulation tool, very useful in each phase of the product lifecycle of afore-mentioned goods. What is imitate? Imitate is the model that shows the computer is generated, they were described with mathematical means actual or of the production system of the tentative idea run. The dynamic simulation that the computer makes is described with graphical format normally, the job between the resource in the system in specific time concerns. Dynamic imitate can be random (involve statistical input and output) or affirmatory (the fixed input that needs to generate fixed output variable is variable) . They also can be disperse incident imitate (the model involves random event, every incident all brings about condition to change) or successive incident imitate (basically use differential equation to build a model) . Note model stock flow model is affirmatory, successive incident imitate. Manufacturing data is mixed between manufacturing facilities the dynamic and mobile imitate inside factory workshop is random with disperse incident model. Simulation tool can serve as those who produce sample or method of whole production system testing to replace. With production sample or trial production photograph are compared, they have time to compress, physics shrinks put and the advantage such as experimental control, the most important is to still reduce risk and cost. Build model, imitate is in with superintendency environment in going several years, superintendency branch emphasizes increasingly " be based on science add up to compasses sex " , get the encouragement of these orgnaizations, increasing company change builds model and imitate to use. Imitate is implementation adds up to compasses sex is cheap and effective method. It can be used at develop and be being quantified to be used at evaluating with what reduce design risk " suppose " design program and operation environment. The demand of the solid to design and running a respect to ask theory that this satisfied superintendency branch to increase increasingly. It is not to have deniable fact to the new requirement that closes compasses sex level. Goods designs inadequate, production quality inferior, safeguard undeserved, and the medical apparatus and instruments that the user uses improper to all can bring about generation off quality. 1990, american food and medicaments management board report, in the concerns with quality problem that creates own recall medical apparatus and instruments, the problem of 44% is created. Considering all these elements, showing stage by stage to the demand of effective simulation tool. The announce before imitate can make appear on the market (510K) or before appearing on the market, approve (PMA) flow is more efficient. For example, PMA need appliance produces main body of a court verdict (DMF) , it is had produce feature of flow, physics about appliance, and the is based on science detailed control information of the tentative idea. These are the can demonstrate effectively all and detailed information in imitate. 21 CFR § 820 requirement quality system detects not only and all prevent a problem with DIN-ISO 13485, and the prime cause that should analyse failure. ICH Q8 of no less than defines in that way, quality comes from the concept at the design, the requirement is continuous rise with define flow beforehand " design space " relevant production flow (" design space " one word is to point to already can be ensured by the proof the flow parameter limits of quality) . Flow imitate is the tool with a kind of powerful function, because they allow to decide ahead of schedule, evaluate and measure flow " good position " or " design a space " , and the probability of deviate ideal condition, can prevent Fan Feng a place difficult of access thereby. This mirrorred simulation tool " suppose " function. When real time contrasts real operation and Utopian operation, imitate still conduces to flow emulating. This kind of tool was represented efficient the method with economy, and these methods can realize more consistent quality, rise to design and manufacture efficiency, and the cost that reduces implementation to accord with code to ask. How does imitate affect flow efficiency to run efficiency the basis is normally overall equipment efficiency (OEE) measure, this kind of Standard Dimension is capacity of affirmatory and true plant " optimal practice " method. Of OEE measure need to combine 3 dimension to spend, use time effectively of equipment namely, can last and reduplicative function is behaved and can produce character to measure. Computation it is OK that these 3 dimensions are spent get be inside product lifecycle, with as far as possible the odds that low cost realizes top quality continuously. The production efficiency of medical treatment manufacturing industry already the average level under manufacturing industry. The OEE level of pharmacy industry uprights more between 15%~30% . The OEE standard that medical apparatus and instruments makes is a bit better, but be equal to for certain or under the manufacturing industry of 60% average level. OEE level is under the factory of medical apparatus and instruments of 50% in industry of medical treatment product not scarce. these and car component and semiconductor production photograph is compared, the characteristic that car component and semiconductor make has the world's top-ranking OEE level, interpose at 85% or inside taller limits. These data explained why manufactory of most medical apparatus and instruments has " invisible factory " reason. The ability of this recessive factory is dissoluble for the needless machine down time, loss related to flow, reject or new treatment, and inefficient attemper wait for element. Compare with other industry posture, because this industry needs to groom and satisfy the requirement of code, wait through work overtime or extending manufacturing time so temporarily the solution will enlarge output, reduce a loss, appear more difficult. Can discover and the oldest rate decreases " hidden output " dynamic imitate is a kind cheap and powerful solution. Traverse the following field, imitate is OK better use resource: (1) defective goods analysis: Defective goods also calls the product that does not accord with a requirement, explain craft controls out of control, pass imitate to be able to discover its prime cause quickly; (2) modification control: Evaluate a plan inside or outside the plan, change convection Cheng and its pilot effect; (3) production breakdown restores: Undertake to breakdown mode qualitative with quantitative analysis, and make preventive, malfunction in order to prevent again; (4) stream of people builds a model with content shedding: Undertake modulatory to some part or the ability that are facilities of entire factory production, so that restore from inside producing breakdown or other event; (5) the production methods such as production of profit of the seed that propose form, to its the effect undertakes quantifying; (6) groom with attestation tool. The imitate imitate of product and mould level had changed the design method of product of plastic medical treatment greatly. Before make sample or beginning to make manufacturing model, can undertake building modular imitate to new design, thereby better improvement notes model craft related its. This makes manufacturer can be forecasted and prevent potential product quality defect, improve product quality thereby, reduce waste. The computer of this level of SigmaSoft, MoldFlow or MoldEx and so on assists a project (CAE) the craft noting model that the tool can make you try differ, undertake to different parameter sensitivity is analysed, and improve the whole process that note model. These design the place of the ability confine of the tool to depend on, the understanding of plastic to a lot of at the new-style project of industry of medical treatment products using craft character is not quite deep still. The imitate of product level must be built go up in the foundation that to stock flow assumes the condition understands, need to undertake stock checks sometimes. The relevant imitate altogether that can carry out in product level has 3 level. The first level is modular antrum, note model namely itself, the analysis of this level helps antrum of your imitate model fill up, cool and protect pressure. Can decide pressure and temperature distributing on one hand the relation between, can decide a wall on the other hand the relation between appearance of geometry of position of thick, runner, product and stock fluid attribute. The goods that because had be notted optimize,corrects fills lapping defect of the tired energy of life that creates in modular process, be in harmony, cave and the relevant product quality such as the fragile area of structural sex risk. From this, can fill intensity of machinery of modular circumstance, product and dimension public errand to make to main inject ahead of schedule evaluate. Nextpage in addition, OK still imitate runner and flow path system, and fill up its and product the analysis incorporates consider. When designing flow path system, important part depends on the flow path measure with the most appropriate computation, evaluate the parameter such as the pressure loss when adopting flow path system. To mould of much model antrum, be necessary to evaluate the balance sex that charges a pattern. Finite yuan of analysis (FEA) the character of quantity of heat that is used at knowing whole pattern accurately and physical characteristic, can use it to carry out more sophisticated analysis. In this level, if need what from fluid, temperature and mechanical intensity angle analyses whole product further,fill up process, also can use more high-ranking computation hydrokinetics (CFD) simulation tool. Those complex integrated physics processes are affecting the integral property performance of Injection Mold Tooling. Case 1: Product scale model sheds an analysis to be in this give typical examples, the tired spirit appearance on the face of a certain function that uses a model to shed an analysis to remove product of a medical treatment, this tired smell situation rises as a result of the platoon undesirable cause. Graph 1a model sheds an analysis to forecast the generation of tired gas, graph 1b shows the quality defect on real product. To remove tired gas, imitate 0. 3? The diversion with thick Mm (graph 1c) , regard improvement as the method that fill up. Graph below the circumstance that the tired spirit appearance on the face is in the 1 a certain function that uses a model to shed an analysis to remove product of a medical treatment not to affect goods function sex, through raising the kind with local large wall, guide flow path can increase the filling velocity of goods. Guide flow path regards goods as final step of the architect normally. Case is here medium, runner position must be on the functional area of goods, otherwise the wall of another area is large will must reduce. Before the other improvement of test and verify plan cannot satisfactory. Imitate affirms the position of blame function area on goods uses the feasibility that diversion not only, and still through relapsing imitate optimizes this plan (graph 1d) . Case 2: Imitate of level of product of great majority of imitate of mould level CFD notes overweight flow path layout and fill up, protect pressure, cool and be out of shape problem. They did not consider the temperature in actual mould to distributing inhomogenous circumstance, assume temperature agrees however. More advanced software can assess omnibus physical situation, these circumstance drag in interact to use to melt stock and mould, the lopsided sex that such as brings about by shearing force, plastic raw material mixes and the element of complex product geometry form. Right now, CFD of hydrokinetics simulation tool is the tool that should use in these circumstances. Case is here medium, the heat that Ansys uses at evaluating heat to cut behavior to shed billabong board to heat balances the effect that the gender causes, path of this thermal current is the medical treatment products plan that pledges for PET material only. With the likeness of plastic raw material of a lot of medical treatment grade, PET has tall viscosity index, incidental when inject by cut the agglutinant and calorific condition that cause. Quantity of heat is finite yuan of analysis (FEA) show, heating the 250 ℃ between the circle heat up gradient (graph 2a) . Besides the difference in temperature of 25 ℃ , return existence to cut the possibility that brings about fuel factor, the proposal uses analysis of hydrokinetics CFD imitate, with the rationality that affirmed pattern designs, these moulds design element to shed analytic guidance through the model only originally. The simulation of influence Ansys CFD that graph 2 Ansys uses at evaluating heat to cut behavior to shed billabong board to heat up balance sex to cause to heat announces, because the collective heat of melt stock and mould rolled steel conducts effect, anticipate the temperature inside flow path will be elevatory, lopsided difference in temperature has the quantity of heat that forms finally only 14 ℃ (graph 2b) . These analysises make as a result the architect can affirm final flow path diameter is mixed heat distributing, optimize the system that the design balances into thereby. Sheet covers manufacturing system and incident of disperse of workshop level imitate, random, dynamic imitate to be able to be forecasted change as time, producing control parameter is how to transfer from a steady state of another steady state. Lie with what simulative of modular shedding analysis differs at, the part builds the input parameter of standard model to be occupied with all computation over, is not to be based on fixed cost. Systematic operation and control logic parameter already built a model as discrete data, and take the design from the system. However, the dependability that produces a system and flow parameter must be obtained with computation or observation, and ought to define probability distribution, and rather than uses discrete data. All sorts of production situation that imitate will come to and current condition (fiducial circumstance) undertake comparative, so that realize likely first-rate,produce a condition. Case 3: The OEE of overall equipment efficiency of system of the single production that note model optimizes this give typical examples to involve many elements: (1) system of a production that note model is contained send an unit automatically, this device will before the part of medical treatment product that has assembled what mention partly sends the system that note model; (2) the part that assembles the part into makings conveyer belt sends the plane that note model, in its exterior jackknife notes model; (3) in giving makings conveyer belt to send one each to use rotary table goods, undertake be assemblied finally. Nextpage passes motion study of a few days, got the data of fiducial production condition. We discover this kind of method wants to compare the one by one on the PLC module that from drive departmental cent works to download an operation to record more economy. Current condition (fiducial circumstance) show: The element that eliminate mould changes, the overall equipment efficiency of product line (abbreviation " OEE " ) what stability is in this 62% to cannot be accepted is low-level go up (graph 3) . It still showed 2830 / the crop of H product already greatly under 3600 / produce of H potentially can. Of each module of whole production system use photograph contrast more balanced, be defeated makings dial switchs on the mobile phone with what record model machine rate is very high still, they did not show in steady state working change trains is " await " or " jam " the clear trend of the state. Graph the overall equipment efficiency of 3 product line but the percent defective as a result of Injection Molding is tall, the average latency time that can create a makings dial is long, expose the issue that gave a pattern quickly from this. This mould is put in the problem with lopsided quantity of heat, among them a kind of plastic raw material that is being used is tall viscosity PET. Analyse discovery further, the hydrokinetics CFD imitate that describes in front suggests to was not carried out. From this, be in " fundamental condition " on the foundation, we were analysed " suppose " condition, include to renovate the condition of the mould among them. Graph 3 in the OEE that imitate gives can rise to 85% , this kind of rapid promotion enough proves the investment that renovates a respect in the mould is complete worthiness. Case 4: The OFE in the workshop that note model optimized this case to describe integral plant efficiency (abbreviation " OFE " ) , the main body in case is jackknife of a production goods of the medical treatment that note model records model plant. The situation of system of a few production of this factory is bad, and visit discovery to still a few other conditions pay close attention to urgently through the workshop: (1) the able-bodied person that the product treats is concentrated the level is unusual; (2) lack seed profit to create a concept (existing production model is OK described as " turn pattern " system) ; (3) the technical platform of the machine that note model is sundry, without uniform standard, the mould also does not have standardization. In addition, the mould changes and unforeseen stoppage time grows make the level of OEE of overall equipment efficiency of system of the single production that note model more low. The conclusion that the OEE after imitate mould is renovated can reach productivity of system of the single production that note model rises significantly. Now our challenge is: The result that wants imitate to rise in the level in system of the single production that note model not only, and want imitate the result that other proposal improves to the factory. Found fiducial circumstance imitate according to time and motion study again. The conditional application that raises imitate utilization rate of equipment and installations arrives in fiducial circumstance. Eliminate mould and equipment to cannot confuse used case, introduce mould standardization and standardization production to accelerate the rate that change a pattern, these practices can raise the utilization rate of afore-mentioned equipment. In addition, still used " help style " or " produce according to order " manufacturing schedule plans a system or stepless plan arrangement comes production of imitate seed profit. Graph 4 in showed simulative workshop is fiducial circumstance, in producing chart to show faster growth " the product is had rate (WIP) " level, and the manufactured goods of low turnover rate (FG) expensive stock circumstance. Graph 4 still mirrorred after all tentative ideas are improved simulative workshop " the condition in the future " , condition is shown in the future " the product is had rate (WIP) " not only inferior (from average 567 tray glide to 347 tray) , and still maintained stability. Condition still behaved level of inventory of manufactured goods FG in the future inferior (average 249 tray) , and the stock turnover rate of manufactured goods FG is increased. Include to change what the model causes to stop machine element inside, the OEE of overall equipment efficiency of whole workshop from former 57% rise to 69% , and calculate a product prompt delivery rate will rise substantially. Graph fiducial circumstance looks into 4 simulative workshop to no matter be affirmatory,did not come, of random, disperse still be based on successive incident, dynamic imitate is the powerful tool that applies to production of medical apparatus and instruments to optimize. Because can advance the analysis of type to produce the chain effect of the problem to factory workshop from mould model antrum, a series of imitate that contact each other so are very useful. Make a demand for coincidence method, imitate also is indispensable tool. It makes the user can have an insight into not only products plan, and still depicted manufacturing system behavior and systematic commutative dependence. On this meaning, manufacturer of medical apparatus and instruments can use imitate to regard main tool as implementation " 21 centuries CGMP " standard, in carry out system of ICH Q8 quality, mention " quality results from design " and " improve continuously " idea. Implementing an imitate project is the economy of a price, means that provides cost effectiveness extremely, reducing while code superintends attestation cost, can improve products plan and production efficiency. No matter be,model is noted to produce a field in goods, the other field that still creates in medical treatment (be like pharmacy) , the circumstance is such. Bigger range ground uses imitate technology, can make medical treatment goods notes model company to achieve taller production efficiency, accord with code to ask better at the same time. CNC Milling