A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS AND PHARMACEUTICAL INDUSTRY
Our 11th Year of Publication
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Seminar Report

Medical Plastics : Materials, Applications And Processing

For Medical Devices And Pharmaceuticals Industries

EFFECTIVE MOULD MAKING

Planning & Coordination for Medical Components

Investigative Tools - Computer Simulated Performance

Predictive computer analysis such as mold fill, mold cool and part stress analysis can help significantly by identifying potential problems before the mold design is started. It is important that these techniques are used prior to the lock in of final part design and mold construction.

These tools provide detailed information about the part design with respect to its ability to be molded efficiently. A mold fill analysis will show the various stages at which a part fills, providing information of where venting is needed to prevent potential problems with material burn areas. The analysis can be run several times using different gate locations, making it possible to determine the best gate location before the mold construction process is started.

These tools can save considerable time in the project scale up cycle if they are used at the proper time and are used as tools to guide the final part design process. These services are available through engineering service companies, mold makers or through the resin suppliers as a part of their overall service.

Single Cavity Prototype Tools
Single cavity tools should be used as a part of the project scale up process. This step is important because it validates the decisions relating to part and mold design and sets the stage for the construction of higher cavitation molds to be made with minimal risk.

Parts run form single cavity tooling improve the entire scale up process in many ways.

i. Increase the cycle time which effects the product cost
ii. Creates particulate matter through the grinding and recycling process
iii. Creates the need to recycle and regrind resin back into the process
iv. Uses more energy to process the resin used to form the runner
v. Variations in the virgin resin/regrind mixture causing change in:

  • Part dimensions

  • Color

  • Melt flow of blend

  • Process conditions

The selection of a hot runner system, the part design and the mold design that goes with it must all be panned together to achieve maximum benefits. The Tooling Engineer must work closely with the hot runner supplier to select the type of system that meets the requirements for the type of part and the material under consideration.

The system selected should be designed into the single cavity prototype mold to insure it meets all the needs of the project. This stop cannot be emphasized enough. There is a significant amount of technology involved in the hot runner system. The single cavity injection mold will prove out most of the decisions that will be made concerning the hot system design and the tool design that surrounds it.

Some important areas to consider in the mold design process are as follows:

  • Selection of specific hot runner design with special consideration for:
    a. Gate vestiqe requirements
    b. Part design
    c. Gate location
    d. Material specified
    e. Mold cavitation

  • Provision of adequate water cooling designed close to the gate area

  • Distance between cavities

The use of a hot runner system will increase the cost of the production molds, but the money spent up front will be returned many times through the quality of the parts made and the savings gained through energy savings and cycle times.

Production Mold Design and Construction

All the planning and work that has occurred up to this point must now be incorporated into the product mold design and construction process. The tooling engineer now understands how the parts ran ton the prototype mold. The part design, the hot runner design, the cool stack up mold cooling and the mold action sequence have all been evaluated. This work must now be translated into production molds.

The size of the production mold now is an important step to consider. The part design along with its tolerance requirements are two critical factors that influence mold size. The part design may require the use of secondary side action. Secondary mold actions will require moving steel segments that will significantly increase the spacing between components.

Tolerance requirements are an important consideration in the determination of mold cavitations. It is well understood that as one increases the number of cavities in a mold, the ability to control tolerances becomes more difficult. The graph below shows a study performed on the relationship between the number of cavities/mold and the resulting tolerance ranges for a particular part.

The control of steel component tolerances and the alignment of these components are also important. If a particular dimension requires a tolerance of .004" and the steel dimension varies by .001", 25% of the tolerance range is given away before plastic is even injected into the mold. If the particular dimension is carried across a mold parting line, the concern of part tolerance is further magnified. The alignment of A side to B side can vary by as much as .005" (or more) through the normal wear of guide pins and bushings. A .005" misalignment in the parting line would cause a dimensional change of .010". The result is a total loss of tolerance control, caused by the steel, before plastic is injected into the mold.

It becomes clear that the control of steel tolerances and the alignment of components is critical in the production mold process. Component dimensions must be carefully reviewed with mold designer and tool shop during this phase of the process. It may be necessary to hold a steel tolerance by as much as .0002" in areas where part tolerance range for a part tolerance of .004".

The use of tapered interlocks between the components is important to control parting line alignment in many medical applications. Tapered interlocks will override the problems of plate alignment associated with leader pin and bushing wear.
When selecting steels for the mold plates and components, it is preferable to use a stainless steel such as type 420 where there is contact with cooling water. The purpose being to reduce problems with rusting wherever possible. The selection of steel for cores, cavities and strip bushings requires careful planning that goes beyond the basic concerns for corrosion. In areas if high wear, where there are parting lines or slide shut offs, special tool steels that offer toughness and/or shock resistance must be considered. Some examples of steel with these qualities may be A-6 or S-7.

The heat treatment process must be carefully selected to establish a finish hardness that is correct for the application in the tool. When two steel surfaces come in contact in an area expected wear, the two steels should have a distinct difference in hardness. This will prevent the incidence of damage from occurring to both components and will promote a good bearing surface between the two steels.

The use of mold coatings is an important area to be reviewed during the selection of mold steels. Mold coatings should be used on components that cannot be stainless steel and come in contact with cooling water. Typical coatings for this purpose may be chrome, nickel or armoloy. Mold coatings should also be considered in areas to reduce the wear between components or in areas where release qualities, between the plastic and steel, are desired. There are many types that could be considered for release purposes. The following list covers some of the most commonly used coatings.

  • Chrome

  • Armoloy

  • Titanium Nitride

  • Teflon nickel composite coating

  • Tungsten disulfide

Summary
The process for constructing injection molds for medical components has become more complex as the medical industry places higher demands on plastic products. Medical companies are expecting molders to provide parts that meet all their requirements of dimensional stability, low cost, fast turnaround and particulate free (clean).

The Tooling Engineer must coordinate communications between many groups of people in order to meet the demands listed. It is clear the task required detailed planning and cooperation form all the resources involved. The Tooling Engineer should have experience with tool design, mold making, product design and injection mold processing. In addition, the person should be trained in good project management techniques. Management and coordination of the steps outlined in the flow chart (attachment #1) will keep the project proceeding in the right direction and will increase the chances of a successful completion and a happy customer.

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