Quality Solutions for Injection Molded Plastic Components

Companies require quality injection molded components consistently. Today quality is what makes all the difference.  Below are quality certifications, tools and equipment to help achieve the highest level of quality plastic components and devices.

Quality Certifications & Registrations

Quality assurance is a program for the systematic monitoring, evaluation and documentation of the various aspects of a project to ensure critical standards of quality are being met. 

ISO 9001 - ISO: International Organization for Standardization, a third party organization providing confirmation that companies meet requirements for the ISO certifications. The ISO 9001:2008 certification for quality management systems are designed to help companies meet customer needs.   This manufacturing certification standard is recognized globally.  

ISO 13485 - ISO 13485:2003 quality certification is for companies manufacturing medical devices.  Companies that achieve ISO 13485 certification are in line with the Food and Drug Administration’s QSR standards and are globally recognized for conforming to the medical device regulatory requirements.  This gives the injection molding company the benefit of increased efficiency, accomplishing regulatory requirements and monitoring the effectiveness of the supply chain.  ISO 13485:2003 is also a manufacturing standard respected worldwide. 

FDA Registered - With FDA registration your injection molder can manufacture not only components that are distributed to a finished device manufacturer; but to manufacture finished goods device or components that are packaged or labeled for commercial distribution for health related purposes to an end user.   This also means the Quality Management System has to be in compliance with the rules established under FDA quality System Regulation (QSR) as established under the 21 Code of Federal Regulation (CFR) Part 820 (Medical Devices).

ITAR - ITAR: International Traffic in Arms Regulations set by the United States government. This set of US government regulations controls the export and import of defense related product and services on the United States Munitions list, which is a list the US government deems as defense related goods, services and technology.    This means your injection molder has control over the following: all employees must be able to work in the United States legally, all product identified as ITAR must be controlled, identified and secured, technical information must be identified and secured including electronic data, blue prints, BOM’s, work instructions, and email, and all facilities must be secured at all points of access as well as visitors must be escorted after access is granted.

Read More

Seize the Expertise of a FDA Registered Injection Molder for Your Medical Device

Any company involved in the production and distribution of medical devices intended for commercial distribution in the United States is required to obtain a registration with the FDA.

Most companies who seek to produce medical devices are required to register and to list the devices and the activities performed on those devices at that establishment.

The registration is completed once the Quality Management System is in compliance with the rules established under FDA Quality System Regulation (QSR) as established under the 21 Code of Federal Regulation (CFR) Part 820 (Medical Devices).

Clean Room Injection Molding for the Medical Industry

A clean room is a location that maintains a controlled level of environmental pollutants - also known as contamination.  These pollutants may include dust, chemical vapors, aerosol particles or airborne microbes.

Clean room areas require a steadily maintained level of control of these pollutants which lead to part contamination. These particles are measured as per the amount found within a specified area - which is measured by the cubic meter of air.

  •  A certified ISO 7 clean room is 10,000 particles of pollutants per cubic foot
  • An ISO 8 certified clean room is 100,000 particles of pollutants per cubic foot
Read More

How Injection Mold Maintenance Keeps Your Injection Mold Producing

Your injection mold is an important asset, so regularly scheduled maintenance is crucial to extending the working life of the mold and the quality of products it manufactures. Regular checkups are important, as they can aid in extending the lifespan of the injection mold. Below are reasons why a company should perform injection mold maintenance on your injection molds.

High repair costs

Whoever said that prevention is better than cure knew exactly what he was talking about. During injection mold maintenance, problems will be identified and fixed immediately and impending issues can also be identified and addressed.

Cost of doing repairs are higher than regular scheduled maintenance because once a mold completely breaks down these repairs tend to be more costly, due to the increased damage to the tool and unscheduled production downtime.

Quality of end product

The functioning status of the injection mold is directly proportional to the kind of products produced. In order to get quality results, the injection mold has to be in good condition. Injection mold maintenance is critical to the protection and dependability of the end product’s quality.

Failure to do so will affect quality and start to produce out of spec components. Ignoring the injection mold maintenance will be neglecting your investment which is a high risk to take.

Once injection molds have undergone several cycles qualified manufacturers will perform inspections, maintenance and cleaning. This means scheduling maintenance carefully.

Read More

Reasons Why Over Molding is a Beneficial Manufacturing Process

Though often contrasted, style and substance are not mutually exclusive. Consumers want products that look beautiful while still delivering premium results, and in a world of increasing competition, manufacturers must be able to offer them both. Through over molding, companies can enhance their products both aesthetically and functionally at minimal cost or inconvenience.

An Overview of Over Molding

Over molding is the process of molding one material on top of another. Usually employed to make a product more ergonomic or to make stylistic changes, this process is typically used to combine two types of plastic materials.

The manufacturer uses an injection molding machine to insert raw molten material into the mold. Injection molds can be either vertical or horizontal. Manufacturers tend to get better results with vertical machines, as they lower production costs and increase output by taking advantage of gravity.

Read More

The Value of a Documented Tool Transfer Procedure for Injection Molding

When it comes to tool transfer for injection molding production relocation - following a well-executed documentation procedure is critical. This is what makes it possible to have uninterrupted production.

Considerations for Transfer of Injection Molds from Vendor to Vendor

Avoid the inherent stress of the tool transfer by making sure you consider every angle that might be affected by the process. Some of these considerations include:

  • Choosing a financially stable company
  • Verifying the company has a documented tool transfer process
  • Verification that no steps of the process are missed
  • All pertinent tool information transfers should be verified

Make sure you discuss details such as project time lines, expectations and frequency of project updates with your injection molder as early as possible in the tool transfer process.

Documented Tool Transfer Procedures

A tool transfer team should be in place from the very beginning of the evaluation process. The strongest teams consist of a representative from each of the most pertinent departments.

Engineering through production departments need to be appraised of the documented details of the tooling project process so they can understand what to expect when the tools arrive at their facility.

Forming effective partnerships is also essential. Items that need to be provided to your injection molder for the evaluation and start of the project are as follows:

  • Drawings
  • Mold specifications
  • Part information
  • Production details
  • Any other value-adding information or auxiliary equipment
Read More

What is Total Cost of Ownership for an Injection Mold

Because the purchase price of an injection mold, naturally is the first thing that comes to mind, is just the tip of the iceberg when it comes to the impact that a purchase can have on your business.

Read More

Find Solutions for Your Medical Device at MD&M East in New York City

MD&M East (Medical Design & Manufacturing) connects the brightest minds at the East Coast’s largest Medtech Event on June 9, 10 & 11, 2015. The leaders of the medical and specialty device manufacturing fields are supporting innovation and evolution in the marketplace.

Enhance your knowledge and understanding of the latest industry innovations and emerging technologies including: contract manufacturing/manufacturing equipment/cleanroom & sterilization/design services/medical grade materials/electronic components/packaging & labeling/3D printing and more.

You will find resources to solve your toughest medical device design, engineering, prototyping, manufacturing, assembly and packaging challenges. Whether you have an active project or an upcoming project, you’re certain to find what you need.

To this end, special conferences and exhibitions are organized to bring all of the most important players together. This speeds development processes, connects critical knowledge base carriers together and dramatically assists innovation.

Medical Design & Manufacturing East (MD&M East) has developed an ongoing approach to keep this connection between groups of medical device development professionals adding to the inspiration, partnerships, education and technologies needed.

Market leadership for injection molding processes and specialty medical and other device manufacturing will be presenting at this event by hosing booths focused on providing services to ease and support the device manufacturing process.

Read More

Advantages of Utilizing Robotics in Plastic Injection Molding

Robotics in plastic processing is the natural progression of technology. It has ushered in a plethora of possibilities that have improved and supported the industry dramatically. 

Motivation for implementing robotics and downstream automation has primarily been to increase productivity, reduce cycle times, increase part quality and facilitate the assembly of small harder-to-handle components. 

Most robots are designed to be helping hands and/or high-tech tools. Using robotics to complete as many tasks as possible generates more time and resources for other required hands-on processes.

Robots are programmed to carry out specific repetitive actions without variation. It is done with extremely high degrees of accuracy. These actions are determined by programmed routines that specify the direction, acceleration, velocity, deceleration and distances. 

Industrial robots often use precise guidance and have the ability to adapt to different part-types using intelligence-based features. These features include; vision, integrated force and sensing capability. Because of this, robotics enables manufacturers to achieve specific levels of flexibility, multitasking and automation of a variety of functions for lower-volume applications.

Read More

Why You Must Optimize Cooling and Venting in Plastic Injection Molds

Two aspects of injection mold design that have great impact on part quality are cooling and venting. If the injection mold has poor cooling, the result could be increased cycle times, scrap and dimensional problems while inadequate heat could result in short shots and poor surface finishes. Venting allows for displaced air in the cavity to escape. If there is inadequate venting, gas burns or non-filled parts can result. If there is too much venting, excessive flash will be the result.

Optimizing Cooling

The biggest problem with the cooling process for plastic injection molding is that a poorly cooled part increases issues that are difficult to resolve. Some of these issues include an increase in cycle times, an increase in scrap, as well as additional problems with part dimensions.

This is why optimization of the cooling processes is so important. Cooling includes a lot of variables such as:

  • The thermal properties of the plastic being molded and the materials used in mold construction
  • Energy balance from melt preparation to cooling cycle time
  • The influence of coolant flow rate on heat transfer efficiency 
  • Mold temperature controller selection
  • Quality design practices for optimum mold cooling

Every plastic part produced requires very specific amount of energy to plasticate solid resin pellets.  This means that an identical amount of heat energy needs to be removed before it will form a stable part. It is important to remember that energy out - needs to equal energy in.  

Read More

Scientific Injection Molding Facilitates Quality Plastic Components

To best accomplish consistency for the highest quality plastic injection molding components - sound principles need to be applied across the field. Scientific injection molding principles are the only approach to repeatable quality product.

Repeatability is key for injection molding. The nature of this process provides the ability to produce the exact same device over and over with exactitude. Repeatability is essential for considering medical devices - as sterility and precision, process validation and control are of utmost importance to create true reliability. 

There are several factors that effect repeatability: 

  • Fill time for the flowable material into the mold 
  • Screw design 
  • Consistent melt quality 

Critical advantages are achieved anytime these common principles are applied to the process. It is the only way to consistently accomplish controlled production end products. 

Read More

Sign up for our Newsletter