Drying Bioabsorbable Resins

February 5, 2010 in Bioresins, Injection Molding, Plastics / Resin by brentb | No comments

Drying is an important part of the process for any product made of hygroscopic (meaning affinity for moisture) thermoplastic.   For medical implants made of bioabsorbable polymers, dryness is particularly critical.  Inadequate drying can produce a variety of problematic results.  These include:  lack of tensile properties and impact resistance, as well as varying flow characteristics.

Bioresins, much like other hygroscopic thermoplastic resins, can suffer three types (or a combination of these three types) of degradation:  thermal, mechanical or hydrolytic. In most thermoplastics these types of degradation occur chiefly during the molding process. With bioresins such as the PLA, PLG , and PGA families, hydrolytic degradation also occurs before and after the molding process.

An implantable device must decay or degrade in the body as part of the absorption process. Different materials and part designs have different rates of degradation in the body (where it is in a moist environment).  The rate of degradation and retention of mechanical properties is affected in no small degree by the way the resin was dried and how the dried resin and finished part were handled.

If a bioresin grocery bag degrades quicker than it was designed to, the results can be the bottom falling out and groceries on the ground. If an implantable device degrades quicker (or slower) than designed to, the results can be harmful to the patient. The degradation process of the implant is key to resorption in the body.

Run of the mill dryers are generally not sufficient to control the moisture as well or reach the super-low moisture levels desired for absorbable implants. Many implant molders opt for vacuum dryers or compressed air with membrane dryers.  Since most implants are small, vacuum ovens designed for lab use is another option for resin drying.  In any case, the drying schedule and temperatures provided by the resin manufacturer must be strictly followed.

In many cases, the resins must be dried to less than 0.02% (200 ppm) and the resin and finished product must be maintained dry. This requirement mandates an inert gas such as nitrogen atmosphere in any non-vacuum dryer hopper, humidity controlled atmosphere in the cleanroom, vacuum packing with a desiccant and nitrogen, and refrigerated storage of the resin prior to drying.

It is not enough to strictly follow the drying and handling procedure, the resin dryness must be well tested, documented, and controlled.  The dryness data is so important because it must be correlated with part degradation data to be able to predict implant device performance and absorption in the body.  Lost weight or halogen type moisture analyzers are relatively economical devices but should be equipped with data acquisition and logging technology.

Drying bioabsorbable resins requires specialized knowledge, methods, and equipment, but is key to successful bioresin implant molding.

Life Expectancy of an Injection Mold

December 18, 2009 in Injection Molding, Mold Making / Tool Building by brentb | No comments

Of great interest to buyers, accountants, quality managers, toolmakers as well to, of course, molders, is the projected service life of an injection mold for thermoplastics.  Many people in the injection mold industry use the SPI Mold Classifications as guides for estimating the expected life of a mold. The common classifications are:

  • Class 101

For a life in excess of a million cycles, with a hardened mold base (minimum of 28 R/C), hard molding surfaces (minimum of 48 R/C) with other details of hardened steel. Guided ejection is mandated as are other features such as wear plates for slides. Parting line locks are mandated, and corrosion resistance is suggested for cooling channels. This is the highest quality of the SPI classifications, usually accompanied by the highest price.

  • Class 102

This is specified for a lifetime not to exceed 1 million cycles. This features the mold base hardness of class 101, molding surfaces (cavities and cores) also feature the hardness specified in 101, and functional details are heat treated. Parting line locks are recommended. Guided ejection, wear plates, and corrosion resistance of water passages are not mandatory, but dependent on expected total production quantities. If expected cycles approach the maximum, then these features should be specified.

  • Class 103

Aimed at molds intended for under 500,000 cycles. These are molds for low to medium production needs, and corresponding price ranges. Mold bases are at least 8 R/C and cavities and cores in excess of 28 R/C. Any extras must be agreed upon.

  • Class 104

For less than 100,000 cycles and limited production. These are lower priced molds. The base can be aluminum or mild steel. Cavities and cores can be of the same or a metal agreed upon.

  • Class 105

These are for cycles less than 500 (prototyping only) and are very inexpensive. They can be of cast metal or epoxy.

These SPI, or Society of the Plastics Industry (http://www.plasticsindustry.org), classifications should and do take much of the guesswork out of estimating the useful life of an injection mold, but not every class 101 mold is the same, and this is true in all the mold classifications. Classifications indicate, but don’t guarantee quality.

No matter the class of mold, how the molder treats the mold can determine the life of the tool. I have seen and heard of aluminum molds that have lasted for years, indeed decades, and conversely witnessed class 101 tools rapidly turned into junk.  Much of what the molder does, or how he treats the tool will determine the life of the mold.

Never over-clamp (use more than required clamp force) the mold not only will you wear, stress, or deform the steel prematurely, you will peen closed the vents, leading to a viscous circle of more injection pressure being dictated and then even more clamp force.

Don’t neglect preventive maintenance on the tool, devise a schedule or consult generic schedules, or better yet consult a reputable mold builder. Taking the mold down for a day or two for PM can add years of life to a mold. If you don’t have in-house tooling capabilities for this you can contact a mold builder such as Matrix Tooling Inc. A great part of mold PM is disassembly and cleaning and replacing components such as springs, o-rings, and pins. Many molding shops designate a person for these relatively simple but extremely important tasks.

Don’t skimp on mold protection, sometimes called low clamp pressure. You want to be set “fat” enough to stop the mold from clamping well before a possible stuck part is crushed by the mold faces. Your press maker can train you in this if there are any doubts. Many mold protection settings can be defeated by closing the mold too fast. Never slam a mold closed. Where there are slides or other actions and angle pins, you should slow the movement before they engage. The possibility of saving a half second on the cycle here could cost days of lost production while repairing the damage that a defeated mold protection could produce.

Daily cleaning of mold faces and lubing components such as pins and slides will extend the life of any class mold. Use the right lube for the job: FDA and medical grease where required and high temp grease for hot running tools such as those running PEEK, PEI, PPS and PSU, where mold temps can exceed 400°F. Remember it is the film of grease a few thousands of an inch thick that does the job, so don’t goop the grease on. It is counterproductive and can attract dirt.

Again the SPI classifications can give the molder a good idea of the potential lifetime of an injection mold, but not all molds in any one classification are made equally. One should always have their molds designed and built by a reputable mold builder. A mold builder such as Matrix Tooling Inc. will stand behind and care for every mold the build over its extended lifetime.

Brent Borgerson
Senior Process Engineer (Older Molder)

Dryness of Nylon: an Essential Component of the Injection Molding Process

October 15, 2009 in Commodities, Injection Molding, Plastics / Resin by brentb | 3 comments

Like many thermoplastic resins, nylon has its quirks and accompanying processing considerations. One of nylon’s most notable characteristics is its affinity for water. Nylon is extremely hygroscopic, a veritable sponge, absorbing any humidity in its environment. It is an efficient sponge; quick to suck up water, and slow to give up the moisture.

Moist nylon resin affects the end product, often producing brittle or dimensionally unstable parts. Cosmetics are also affected; splay being one notable cosmetic defect that can be caused by moist resin. If the processed resin is out of moisture specs, it is essentially degraded. This is called hydrolytic degradation, and the effects and symptoms are akin to thermal degradation. Desired characteristics of many nylon parts include toughness and impact resistance. Parts produced with resin that has been sub-optimally dried can lack these traits.

Moist nylon resin can be hard to process. Nylon has a tendency to drool from the nozzle. Good heat control at the nozzle is important for molding nylons successfully and controlling nozzle drool or freeze-off, but wet resin can make this control almost impossible to achieve.

In addition to drying nylon well, it is important to dry nylon consistently. The same nylon resin dried at different moisture levels will exhibit different melt viscosities, even though the moisture levels may be within the manufacturer’s specifications. Water acts as a plasticizer; therefore wet nylon will fill more easily than dry nylon. This is reflected in peak fill (transfer) pressure and can be reflected in fill times, especially visible in a pressure limited process. For good consistent molding results, especially in a product with demanding dimensional specs, the resin moisture level should be consistent from run to run.

If nylon is allowed to stay in the dryer for too long (over the recommended time), the material can start to degrade as well.  Natural nylon may start to turn yellow.  The finished part may also be very brittle.  This is more common on nylons than most materials.

When inspecting nylon parts it is always good to allow the finished part to absorb the moisture in the air before you do your inspections.  Depending on the environment this can take a few hours or more.  Some nylon jobs require a fixed amount of moisture to be put into the poly bag that holds the parts.  This is common in the processing of nylon straps.

At Matrix Tooling/Matrix Plastic Products, we strictly follow manufacturers’ recommendations for drying temperatures and times to ensure dryness, and we have a moisture analyzer to verify the results. We have found that good, consistent drying gives consistent molding results.

Written By:

Brent Borgerson – Senior Process Engineer (Older Molder)

Patrick Collins – Molding Operations Manager

The Value of DOE in Injection Molding

August 28, 2009 in Injection Molding by brentb | 2 comments

DOE or design of experiments (sometimes called experimental design) can be a powerful tool for any molder to have in his or her arsenal.  We live and mold in a demanding era.  We must mold with tighter tolerances, less scrap, and quicker cycles than ever before.

I was brought up by my mentors to change only one variable or parameter at a time, then measure the part or observe the outcome of that change. Curing a defect or establishing a robust process was often a matter of days, weeks or more.

DOE can cut the time for defect remedy, process establishment, and process validation to a fraction of what the old “trial and error” method took.

DOE may sound complicated to many Molders, but where once DOE was the territory of statisticians and engineers, new software developments have simplified the process and interpretation of the resulting data.

At Matrix Tooling/Matrix Plastic products, we use a software package designed for injection molders.  It supports up to Taguchi Level 8 experiments.  We can focus on, say, three inputs or factors in an attempt to achieve one or more desired responses or outputs, also called outcomes.  Factors could include: mold temperature, melt temperature, injection speed, and pack pressure among others.  The response could be anything from warp, flashing, a change in physical properties, or certain dimensions. Choosing inputs and responses requires knowledge of and experience with the injection molding process. This is much more important than being a statistician.

Taguchi L8 experiments require eight runs, and each run will have changes to multiple inputs. Results are measured, noted, and entered into the software which then maps the results on various graphs and charts for analysis, including: response surface graphs, scatter plots, main effects plots, Pareto Diagrams, ANOVA and other high powered statistical tools. In short one can see graphically what parameters or combination of parameters affect the desired outcome. You may not necessarily cure the problem during the first DOE if it is a hunt for a defect cure, but you will likely be pointed in the right direction.

Aside from troubleshooting, DOE is a recognized tool for process evaluation and validation, especially for FDA requirements for the medical device industry. There are a number of methods and tools recognized for FDA evaluation: SPC control charts, capability studies, Failure Modes and Effects Analysis (FMEA), error proofing, and DOE.  Many nonconformities are the result of excessive variation.  DOE can be a great tool to reduce and control variation. Different types of designed experiments are used here to identify key input variables and one kind of Taguchi experiment actually emulates the variation that could be found in a process over time through small but structured parameter changes.

A Molder must use all the tools at his or her disposal to quickly identify key process influences and arrive at a robust process that is defect free.  DOE is a powerful tool, and astute molders should know how and when to use it.

Possibilities of Why a Polycarbonate (PC) Part Is Cracking

July 23, 2009 in Engineering/Medical Grades, Injection Molding, Plastics / Resin by pat | 4 comments

We recently had been asked by a potential customer why a polycarbonate would crack post-molding.  They had been having this issue on a specific part from one of their current suppliers.

Our first step was to ask if we could get a sample of the part and the process sheet.  After looking at the part and reviewing the process sheets we noticed the following:   First, key set points like the dryer settings were not included in the process sheets.  We saw this as a potential red flag.  With polycarbonate it is very important that the material be dried correctly with the proper equipment.  Polycarbonate requires a dryer setting around 240 degrees for four hours (following the material recommendations of course, some may vary around 250 degrees for four hours) but doing this requires a high-heat dryer.   It is always good to verify that the moisture is 0.020% or less prior to molding.

Further looking into the setup sheets we noticed that the injection pressures were all on the high side of the recommended range.  This can be a sign that the gate size or nozzle orifice may be a potential suspect.  Running the incorrect gate size or nozzle size can induce molded-in stress.

We also noticed a lack of process monitoring; the set limits would allow the press to continue to run outside the manufacturer’s recommendations.  If uncontrolled, incorrect barrel temps, pressures or screw cushion can all be reasons for in-molded stress.

In looking at the part, the molded stresses were obvious, particularly when looking through a polarized lens under strong lighting.  The stresses create a rainbow effect in the translucent material.  Our next step was to measure the gate size and we found it to be much smaller than what we would recommend for PC.

So we had plenty to consider from the start, and these are just a few possible reasons for PC cracking.  We’ve also been told by the material manufacturer that some mold release sprays can attack polycarbonate.  They even had a story about an operator whose hand lotion was found to be the culprit for cracking parts.  This is one reason we do not allow silicone mold release in the plant and insure our operators use gloves on polycarbonate jobs.

After ruling out all of the above possibilities, it’s possible that some part designs may require annealing for stress relief.  Annealing of the plastic part is the process of heating the post molded part to just below its softening point, then keeping it at the high temperature for a period of time before cooling it slowly back to room temperature.  This can relieve some molded-in stresses but isn’t a desirable solution in most cases.

Processing polycarbonate at the manufacturer’s recommendations is the key to stress-free and crack-resistant parts.  If, for any reason, you are unable to follow the recommendations you should ask yourself why and correct the problem at its roots.

Written By:

Pat Collins
Molding Operations Manager

The Three R’s of Injection Molding

July 9, 2009 in Bioresins, Injection Molding, Plastics / Resin by brentb | No comments

Plastics have long been associated with environmental unfriendliness and wastefulness of crude oil and petroleum byproducts. The advent of bioplastics (biodegradable and biocompostable plastics) which are derived from renewable sources such as corn starch or vegetable oil is helping to improve the image of plastics among those concerned with the environment, carbon footprints, sustainability, and being “green.” Bioplastics are slowly but steadily being improved, and in some cases their abilities to process and end-use properties can mimic or even surpass those of traditional petroleum based materials.

Bioplastics, aside from being derived from renewable resources, have the advantage of not releasing harmful toxins during their production, processing or degradation. Many conventional plastics can release known or suspected carcinogens such as formaldehyde or benzene during production, processing or destruction.

Growing the sources for bioplastics also reduces carbon dioxide in our atmosphere. Since the production of conventional plastics produces so much CO2 the use of bioplastics in place of a conventional plastic has a cumulative effect, with the substitution of just one ton of bio for conventional plastic having the net effect of reducing multiple tons of CO2 in the atmosphere. This not only takes into account the production methods for each type of plastic, but also the photosynthesis process in growing biomass or raw material for bioplastics. Bioplastics show great promise in reducing both our industry’s carbon footprint and impact on rising global warming.

What can plastics processors do until bioplastics are perfected in properties and reduced enough in costs to truly compete on a large scale with conventional thermoplastics? This is where the 3 R’s apply in injection molding. The 3 R’s in molding don’t stand for “reading, riting and ‘rithmetic,” but rather: reduce, reuse, and recycle. At Matrix Tooling / Matrix Plastic Products, we have been molding with bioresins, including bioabsorbables for a number of years, but as responsible members of the environmental community, we also have been practicing the 3 R’s.

Reduce: Scrap (and resin usage) is reduced through cold runner and sprue size reduction where possible without affecting moldability. In many cases we have reduced sprues and runners to the prescribed percentage of regrind allowed in the product specification. Hot runners and hot sprue bushings also have been used wherever possible. We have also thinned out wall stocks on parts where the product integrity wouldn’t suffer.

Reuse: We reuse what regrind we can and have come up with applications to use up to 100% in-house regrind. We utilize returnable/reusable packaging where possible and where allowed by the customer. We also have a closed circuit water system to reduce consumption and also filter, monitor and analyze hydraulic oil to avoid indiscriminate unneeded oil changes.

Recycle: Where we can’t reuse in-house regrind, we try to find it a good home. We sell the regrind where possible or even give it away for free if it can be used but there isn’t a paying market. Packaging is recycled also. We even collect our soda pop cans!

Matrix is serious about being environmentally responsible, using bioresins, and abiding by the 3 R’s. It not only makes environmental sense, but favorably affects the bottom line.

Written By:

Brent Borgerson

Senior Process Engineer (Older Molder)

Transfer Tooling Programs: Streamlining Existing Molding Projects

May 13, 2009 in Injection Molding, Mold Making / Tool Building by paul | 1 comment

Several years ago, a customer we had limited dealings with contacted us to help supply product that was arriving sporadically from their off-shore partner. Numerous quality issues with the molded parts caused a high scrap rate, and the lure of low cost tooling and production wore thin when product was regularly delayed entering the USA. Matrix quickly built low-cavity tooling to keep a stream of parts flowing, allowing time for the transfer of six tools to the States. Once the tools arrived, the molds were disassembled, damage was repaired and mold modifications were performed to enhance their performance. For the next two years, we ran production using the refurbished off-shore tools. In the meantime, customer demand was increasing and production was ramping up so high-cavitation hot runner tooling proposals were submitted. Part of our proposal to the customer was financial justification calculations, including amortizing a portion of the tool cost into each part. Payback to the customer was rapid, in most cases less than 15 months, and with the faster hot runner tools, part prices dropped dramatically. In addition, quality problems went away, and with Matrix covering the tool maintenance for the life of the program, the cost to the customer was predictable and affordable. For more information on our transfer tooling capabilities please visit our main website.

Written By:

Paul Ziegenhorn
President

Injection Molding Bioabsorbable Medical Implants

April 21, 2009 in Bioresins, Engineering/Medical Grades, Injection Molding, Plastics / Resin by brentb | 1 comment

Medical grades of biodegradable/bioabsorbable PLA, PLGA, and PLG resins can sell for upwards of $1,500 USD per pound. This and the delicate nature of biopolymers can send shivers down the spine of any injection molder. Really though, the standard precautions and best practices of any high level molding operation familiar with running engineering-grade resins similarly apply to the processing of these bioabsorbable resins. Every aspect of the manufacturing process must be closely monitored, and proper procedures strictly adhered to.

Mold construction must take into account the rheology or flow characteristics of the resin, shrinkage, and venting requirements. Due to the relative infancy of the bio-materials there is little data available from the resin makers, so all mold construction should be steel safe. Selection of mold material should keep corrosion resistance in mind.

Cleanliness, of course, is paramount. There can be no contamination present in an implantable device. Purging an injection unit after a run with a different resin, no matter how thorough, is not enough. The screw must be pulled and all residue removed from the screw and barrel physically. Don’t use copper gauze (here we differ slightly from the standard molding procedures) for fear of fragmenting and heavy metal contamination. A plastic abrasive cloth would be better, and the unit should be wiped, dusted, and blown or vacuumed free of any minute debris after cleaning. Having a dedicated injection unit is a better option, with a dedicated molding machine, dryer, and loading system being the best case scenario.

The molding machine really is not specialized. Usually a general -purpose screw is fine with about a 3:1 compression ratio and 20:1 length over diameter ratio (again, a general – purpose unit). Clearances should be tight in the injection unit, and the check ring non-return valve should be in good shape. Bioresins are not very heat or shear stable, so sizing the barrel capacity of the machine to the intended shot size is very critical, and high compression screws are not advisable. Since the resins are so costly, any scrap will immediately affect the bottom line. Savvy molders start and stop the run with a “commodity” bioresin with similar flow characteristics.

PLA/PLGA/PLG for implantables, like most bioresins, are slow to give up their heat and also can be slow to obtain optimum crystallization, so cooling times and pack/hold times can be quite long which lead to longer cycle times. Here, corners can’t be cut by running a colder mold in quest of faster cycles because you risk endangering the end characteristics of the implant.

In addition to shear and heat degradation, bioabsorbable resins are susceptible to hydrolytic degradation. Careful drying is important, with drying in the cleanroom next to the molding machine being advisable. Minimum out-of-dryer/in-molding-machine hopper time is also essential. Like many engineering resins, bioabsorbable resins must be dried and maintained at or below 250ppm (0.025%) moisture. A moisture analyzer is mandatory.

It is important to fast-track the process building and optimization portion of any injection project for PLA implants, if only due to the resin costs. One tool for this is DOE, or Design of Experiments. Here again, process building with a commodity PLA resin and final tuning with the PLA implantable resin is advised.

The implantable device must be made, handled, and packaged under the strictest of cleanroom conditions. Packaging must protect the implantable and be hermetic to keep it from picking up ambient moisture. Vacuum packing with laminated foil pouches is an option, and inclusion of a desiccant in the master carton is also popular. Sealing options include vacuum and heat sealing. Finally, sterilization methods and their impact on product end characteristics must be cautiously considered.

Care must be taken with these expensive and fragile resins; but the discipline is good for a molder, and the results for following good methods and procedures can be quite rewarding.

Written By:

Brent G. Borgerson
Senior Process Engineer (Older Molder)

Avoiding the Consequences of Molding with Wet Resin

February 17, 2009 in Injection Molding, Plastics / Resin by brentb | No comments

In a recent blog posting we discussed the consequences of molding with wet engineering and commodity resins. The best way of dealing with these consequences is to avoid them entirely. In the posting we discussed our procedures and test equipment for assuring that the dryness of the resin is in the correct range. The most important aspect of resin drying is, of course, the dryer and the maintenance of the dryer.

At Matrix Plastic Products, we have a dedicated dryer for each molding machine that runs hygroscopic engineering resins. The dryers are of two types:

1. Desiccant hot-air dryers
2. Compressed air dryers

Key to dryer effectiveness is maintenance. If the dryer goes down, the molding machine might as well be down. At Matrix, we take a multifaceted approach to dryer maintenance.

Visual Inspection: Dryers are visually inspected daily for hose condition, clamps, and kinks. Controls are scanned for dew point and temperatures in the proper range. Air flow cones are inspected as are the air flow filters.

Monthly detailed inspection: This includes the moving parts, testing desiccant condition, and confirming dew point meter readings on the dryer with a hand held dew point meter.

All monthly inspections and maintenance are documented on a preventive maintenance spreadsheet, developed here at Matrix Tooling/Matrix Plastic Products. This sheet covers PM for most common injection molding room equipment and is available for free at: http://www.plasticstoday.com on the maintenance forum and also on Bill Tobin’s WJT Associates website: http://wjtassociates.com/site/.

Since the sheet was developed here at Matrix, it will soon be available on our main website, again, for free. The PM sheet has been used all over the world and is a great tool for any molder to have in his or her kit. So avoid the consequences of molding with wet resin and maintain those dryers!
Written by:

Brent Borgerson
Senior Process Engineer (Older Molder)

Job Losses in Manufacturing

November 14, 2008 in Manufacturing Industry by paul | No comments

Much is published about currency manipulation, unfair trading practices, and low cost offshore labor as primary reasons for the large loss of high paying manufacturing jobs in the USA. One thing rarely mentioned is the concept that the introduction of computer controlled machines and automation have had a significant impact on USA companies need for manual labor. Requirements for labor today are far different than in days past as manufacturers now need higher skilled people, but less of them. Special interest groups often look for easy targets when determining the reasons for job losses, but the bottom line is that in many cases, companies need fewer people to do the same amount of work as before. And as labor costs continue to climb, it’s the first place a manufacturer will look to reduce his overhead expenses.

Paul Ziegenhorn
President

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