A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS AND PHARMACEUTICAL INDUSTRY
Our 26th Year of Publication
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Cover Story

All Electric Injection Moulding Machines for Clean Room Applications

 

Mr Ankur Agarwal
Marketing Communications
Milacron India

The world of medical manufacturing is considered one with the most stringent requirements. To avoid contamination, the concept of clean room is devised. A clean room for a medical process is a controlled environment with low / negligible level of pollutants such as dust, airborne microbes, aerosol particles, and chemical vapors.

Cleanrooms can be classified to a number of standards, the most common being ISO 14644, which is an international metric standard with classification based on the maximum allowable concentration of particles greater than 0.1 m per cubic meter of air. Compliance to a specific class can be made at particle sizes between 0.1 and 5.0 m depending on cleanroom class, design, and process requirements.

Particulate cleanliness classification is normally determined using a discrete particle counter (DPC) and a specified sampling protocol, with sampling sites located on an evenly distributed grid at a height determined by the work activity. A cleanroom is considered compliant if the average concentration at each location, and the 95% upper confidence limit (required if there are fewer than 10 locations), do not exceed the particle concentration limits of the specified ISO class at the considered particle size.

 

Clean room varies in size and complexity, and are used in industries such as

 

Biotech, medical device,
Pharmaceuticals,
Food & Packaging and
Life sciences

 

As well as critical process manufacturing common in

 

Aerospace
Optics
Military and Department of Energy
The key component is the High Efficiency Particulate Air (HEPA) filter that is used to trap particles that are 0.3 micron and larger in size.
Some cases where stringent cleanliness performance is necessary, Ultra Low Particulate Air (ULPA) filters are used.

 

 

Clean room air flow principles

 

Cleanrooms maintain particulate-free air through the use of either HEPA or ULPA filters employing laminar or turbulent air flow principles.
Laminar air flow systems are typically employed across 100% of the ceiling to maintain constant, unidirectional flow.
Laminar flow criteria is generally stated in portable work stations (LF hoods), and is mandated in ISO-1 through ISO-6 classified cleanrooms.
Personnel selected to work in clean rooms, they enter and exit the cleanroom through airlocks, air showers, and they must wear special clothing designed to trap contaminants that are naturally generated by skin and the body.

 

 

Injection Moulding Machine

 

To comply with the clean room standards, MILACRON has developed Elektron an all-Electric Injection Moulding Machine. This machine eliminates the hydraulic components and circuits thereby enhancing the degree of transmission efficiency and reduced losses. Removal of hydraulic oil also results in No Contamination of the product. The Elektron machine is built with enclosed covers to minimize any accumulation of dust particles in the clean room.


The Elektron provides extreme reproducibility, prolonged accuracy and instant repeatability. The low energy consumption results in 40 80% energy savings for the manufacturing unit. It has a narrow processing window for thin walled components in engineering polymers. High uptime, smaller shot size utilization, low emissions, water savings, noiseless environment need are the features of Elektra for a clean room necessity.

 

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