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Injection molding started in the late 1860s with a product called celluloid (made of plant cellulose and camphor) used as a replacement for ivory in billiard balls. The heated celluloid was pushed through a plunger into a mold.
 
In 1912 Leo Baekeland made the first synthetic plastic, it had a phenol base he named it Bakelite.
 
Bakelite was heat resistant and non-conductive and highly moldable, so it was widely used as an insulator, as well as in many consumer goods. 

As World War II wound down and consumer demand for inexpensive products grew the modern era of thermoplastics began.
Injection molding offered an inexpensive, repeatable process that could be used to create a wide range of consumer and industrial goods.

The simple plunger used for the celluloid billiard ball, has been replaced by using a heated screw and barrel so that temperatures and pressures of the melted polymer can be carefully controlled.   

Now everywhere you look you will find items made of plastic, many of them, perhaps a majority, made with injection molding.
If you have never thought before about how many of the plastic products, parts and pieces that you encounter each day are made; this short paper will help you understand it better.   

Injection molding is the most common way that 3 dimensional plastics items are made.

The following drawing shows how injection molded parts are created. The plastic injection molding machine consists of an extruder, a press and a mold or tooling.
   

​Plastic Injection Molding Process for Creating Rigid Shaped Pieces

​1. The machine operator pours the polymer resin into the hopper.(The polymer arrives at the injection molding facility in pellet form, sometime polymer is already colored and other times there is a color concentrate added into the feed hopper) 

2. The hopper feeds the resin into the extruder.

3.  Heating elements and the turning of the extruder screw brings the polymer to the correct melting temperature and forces it through the extruder.

4.Just before the shot of molten polymer flows in to the mold, the press brings the tooling into place with the correct clamping force necessary for the unique part being produced.

5.  As the tool and the molten polymer come together, there may be many moving pieces in the tool to assure that all the necessary spaces within the mold are filled.  

6.  Once the tool is filled, the cooling of the mold begins in preparation for opening the tool. Immediately followed by the ejector pins pushing the parts off the mold. Then the process begins again.

7.  After the parts drop off the mold they may go through many more steps.  

Injection molding is a remarkably cost effective process for many items we depend upon in our daily lives. These plastic injection molded items are found throughout our society:

• -It may be the little cup filled with pre-measured coffee that you put in your one cup coffee maker.
• -They may be part of an assembly in some complex medical application like a knee replacement.
• -Or it could be an automobile dashboard that will go right to the assembly line and be snapped into place.  

TechNH, Inc. is a Plastics Injection Molding Company
We specialize in complex and highly regulated applications for:

• -The medical industry
• -The defense industry
• -FDA  applications

For more information, visit our Web site at:  http://www.Technh.com call (603) 305-7585
 
 
Diagram citation*
Muhsin, Adel. (2014). FEASIBILITY STUDY ON PRODUCING FUNCTIONAL PARTS USING MOLDING TECHNOLOGY. 10.13140/RG.2.1.1465.4322.


 

ASSURING QUALITY WITHIN THE PRODUCTION SYSTEM AND THE JARGON USED IN THE MEDICAL INJECTION MOLDING INDUSTRY
 
 
To assure that the highest standards are met on a consistent basis, all medical injection molders have Quality departments. In addition to this, a select group of injection molding companies have a key employee in the position of Management Representative who oversees the quality requirements, from a macro perspective.  An industry rarity is a company that has a Management Representative and Regulatory Affairs staff overseeing all Quality and Regulatory requirements and activities.

The Management Representative reviews all ISO requirements (typically ISO 13485), and Regulatory Affairs reviews all FDA and other pertinent regulatory agency requirements, to support each Customer’s production requirements. Any company that chooses to have a Management Representative and Regulatory Affairs as part of their staff demonstrates their corporate commitment to meet the Customer’s Quality and Regulatory requirements. 

Any Customer that utilizes their products within a regulated industry can be assured that the Management Representative and Regulatory Affairs will help them work through the requirements prior to production.

If you want the highest quality production environment, be sure that you choose a contract manufacturer that has a Management Representative and Regulatory Affairs on staff.

Common Terms within the Industry

Audit- a systematic, independent examination of a process that is performed at defined intervals and at sufficient frequency to determine if the process activities and results comply with stated requirements and that the process is implemented effectively, and suitable to achieve stated objectives.
​
AQL (Acceptable Quality Limit) – used in conjunction with and established sampling plan to determine the sample inspection quantity for a process. This limit determines the maximum allowable defects by lot quantity size.

FAI (First Article Inspection) – is a formal, documented, enumerated process by which parts from a mold are inspected to assure that all critical dimensions meet the specification on the print. 

cGMP (Current Good Manufacturing Practice) – the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. 

IQ (Installation Qualification) – term used for the verification of the correct installation and function of the mold.

Metrology – the scientific study of measurement.

OQ (Operation Qualification) - is the establishment of the process window and verification standards within which acceptable parts can be manufactured.

PFMEA (Process Failure Mode and Effects Analysis) – an approach to review each step within a process to identify potential failure modes, with the goal of eliminating or mitigating the risks and effects of those failure modes on the process.

PQ (Performance Qualification) verification of the process using real production conditions.

Scientific (Decoupled) Injection Molding – A systematic approach to molding; it examines the principles behind plastics molding, the behavior of plastics during the molding process and the effect of process variables on part fill, pack and hold portions of the process.

Validation – process that verifies the stability of a process to produce an injection molded part.
​
Verification – evaluates plans, drawings and specifications to ensure the product meets established standards.

TechNH, Inc. is a Plastics Injection Molding Company
We specialize in complex and highly regulated applications including:
The medical industry (ISO 13485) - The defense industry (ITAR) - FDA applications
For more information, visit our Web site at:  www.technh.com or call
(603) 424.4404 x153
 


Check back soon for the next installment.

To choose the right partner you need to ask some questions.
​

1. Does my product require a clean room, or at least a portable clean room?
2. Does the partner I am looking for make molds and run production?
3. Do they follow standardized validation procedures like IQ, OQ, and PQ?

Does my product need a clean room? 

Note that it can be said or written either way “clean room” or “cleanroom” according to Wikipedia. However ISO, the International Organization for Standardization uses the term “cleanroom” so in this article we will stay consistent with ISO.

A cleanroom is a facility designed to minimize and maintain a standardized level of airborne particulates. Cleanrooms are labeled most commonly by the ISO standard that is defined by the maximum particles per cubic meter of air in that particular room. The rating standards go from ISO 1 (10 particles per cubic meter >0.1 um) to ISO 9 (35,200,00 particles per cubic meter > 0.5 um). At TechNH we have both a modular cleanroom and a portable cleanroom both class ISO 7.

Does my prospective molding partner make the molds and run production?

Some medical molders run production only. This may be fine for your need, however if there are any wear issues with your mold or you need to improve or change your design in any way then that would need to be done at a mold maker shop. TechNH has both a mold shop (also known as “tooling capability”) as well as production capability. TechNH can help with designing your parts to achieve your production needs by assuring the design is production friendly, not every design is production friendly.

Do they follow standardized validation procedures like IQ, OQ, and PQ?               

Validation is a critical process that establishes documentary evidence that a process or procedure or any production activity maintains the desired standards. Normally any validation procedure will include the IQ, OQ and PQ.  IQ – is the Installation Qualification of the mold. OQ - is the Operation Qualification of the equipment and process. The PQ - is the Process Qualification of a production run. 

TechNH has a complete quality and regulatory department ready to help you and your company.

​This is the first in series of short articles to explain the sometimes very confusing world of jargon and terms used in medical molding. Check back soon for the next installment.  

TechNH has added capacity in the form of six new Nissei injection molding machines. One of these machines is a PNX60, two are FNX110 and three are FNX180 models.  All are workhorse hybrid machines with high precision operation and controllers.  Each offers quick injection response, wide-ranging injection speeds, stable control in ultra-low velocity ranges, long-sustained high injection holding pressure, high-rigidity straight-hydraulic clamping units, and long-lasting dependability. 

These machines are excellent "clean" operators with high energy efficiency, low running costs and energy savings features which will allow TechNH to stay on the cutting edge of environmentally responsible injection molding.  These machines have also been outfitted with Wittman robots, EMI conveyers and Dri-Air material dyers to facilitate proper material handling and process automation.
 
Three of these machine are located on the main production floor but three have been moved into the area previously occupied by our tool room; which has moved permanently into our adjacent building.  This space will be used for molding, laser marking and machining of product.  An overhead crane has been added to this area to facilitate ease of mold installation and to increase the level of safety for our team members. 
​

TechNH is proud to announce that we have added a SmartScope Flash 500 to our inspection department.  It allows us to speed up complicated inspection processes for our customers. The ability of the SmartScope Flash 500 to measure multiple dimensions simultaneously has cut some inspection times by more than half.

SmartScope Flash 500 is multisensor capable and utilizes a high quality AccuCentric zoom lens that auto-compensates with every magnification change. It increases our inspection capacity and allows us to turn your Validation and FAI jobs around faster.

Make TechNH your next call for high quality tooling, production and validation for your complex injection molded part.  If your parts require high standards we can help you. We are ISO 13485 Registered, ITAR Registered, FDA Registered, and UL Recognized. Call sales today (603) 424-4404 x153.  

​The TechNH tool room has moved to its new home in our recently renovated building at 10 Continental Boulevard.  This space, adjacent to our main building, allows TechNH to easily create and maintain tooling while creating no delays in our schedule.  This area has been updated to include new floors, lighting, environmental controls and an overhead crane.  The move of our tool room allows TechNH to increase the size of mold that can be produced internally and opens up space on our production floor for much needed expansion of our molding operations.  This change will allow for new levels of production, safety and efficiency.    

UPDATE - 19 MARCH 2020
 
For our Customers, TechNH is opened and fully operational. 
 
On Wednesday 18 March 2020, the President of the United Stated invoked the Defense Production Act (DPA). The invocation of DPA will allow the federal government to request that companies make needed medical supplies to treat Covid-19 (Corona Virus Disease 2019) patients.

For our Customers, TechNH, is opened and fully operational.

The CDC continues to categorize the current risk level associated with the COVID-19 virus as low. That being said, TechNH believes in being as proactive as possible. 

Per CDC recommendations, the TechNH workforce has been reminded how best to guard itself from flu-like viruses. Additionally, the facility has been outfitted with increased cleansing/washing stations, and there is ample stock of personal protection equipment available for all employees. 

Because TechNH is a medical molder, we pride ourselves on cleanliness of product and personnel. We continue to clean and disinfect items that come into our facility from both foreign and domestic sources.

To date TechNH is experiencing no labor and/or supply chain disruptions, however is proactively prepared should disruptions occur.
​
TechNH is committed to maintaining diligent cleanliness, and continues to monitor CDC recommendations for any changes.

For our Customers, TechNH, is opened and fully operational.

The CDC continues to categorize the current risk level associated with the COVID-19 virus as low. That being said, TechNH believes in being as proactive as possible. 

​It is with great sadness that we tell our customers and friends of the passing of our founder, CEO, and friend, Rich Grosky.  Rich passed suddenly Friday night, February 8, 2019.