Clean Room Injection

Inox Cast Clean Room Injection

Looking for a perfect cleanroom injection process to provide complete product and medical supplies in China? Inox Cast can meet your urgent needs. We can only focus on your cleanroom injection needs and ensure to follow your cleanroom injection details and specifications.

Inox Cast cleanroom injection is one of the important processes to help produce different types of medical devices and components applicable for different types of materials. We can custom your desired product designs, sizes, shapes, prints, types of surface finishing,  and even textures.

Inox Cast has a lot of experience providing different customer’s requests to get their desired customizations. Our clean room injections are accessible in different abilities features, and more. You can get high-speed clean room injection, high precision, high temperature, surface treatment, multi-cavity, and more types of clean room injection.

We ensure our clean room injection passed the standards and supply certified clean room injection internationally to ensure the best performance and quality clean room injection for perfect production output.

Our 20 years of experience made us a trusted custom supplier worldwide. We have complete clean room injection selections to fully support your medical supplies and material productions.

Send the details and drawings of your desired medical products. We can provide the best clean room injection like single and multi-cavity, hot runner, and more offering lesser maintenance, easier to operate, and most especially affordable and suitable to your budget.

Send your inquiries!

Clean Room Injection: The Ultimate Guide

Probably, you are looking for more information about clean room injection molding.

A reason this guide explores everything about clean room injection molding.

Take a look:

1.  What Is Clean Room Injection?

It refers to the manufacturing process of plastic parts in a relatively isolated room specifically optimized to minimize risk of particle contamination.

The essence of clean room injection molding is to ensure production of specialized parts in a clean room surrounding for additional safety and precaution.

clean room injection

All machines and devices used in clean room injection are thoroughly and regularly checked and cleaned.

Besides, walls, floors, tools and workstations must remain sanitary and sterile at all times before, during and after production.

2.  Requirements For Clean Room Injection

The entire process of clean room injection is guided by different directives to ensure standardization, market and safety requirements.

Ideally, the directive states that particulate and microbiological cleanliness and the surrounding production conditions must be guaranteed.

It is also a requirement that air in production premises must be free from germs and particles.

As part of complying with normal regulations like GMP requirements, a commitment to maintain required clean room technology is mandatory.

Clean room injection workers must also wear special attires like gloves, gowns, shoe covers, hairnets etc.

Thus, any particular special attire worn inside the clean room must never be worn outside the area.

In some instances, changes occurring in market conditions are likely to demand respective precautions from other sectors.

Under such conditions, the level of commitment to clean room processing required by injection molders is dependent on product specifications.

Hence, specific clean room adaptations adapted to fit individual specifications must be cost-effective and provide room for expansion.

3.  Benefits Of Clean Room Injection

Primarily, the essence of having a clean room is to adapt to specific industries’ requirements.

For instance, injection molding is a largely used form of manufacturing in medical and pharmaceutical fields since it is versatile, cost-effective and adapts to clean room standards easily.

Therefore, this process guarantees several companies flexibility they need while maintaining the requirements of safety and cleanliness.

Nevertheless, the main benefits of clean room injection process include the following;

Maintaining Hygiene

Clean room injection has settings which enhance product quality and reliability by reducing daily pollutants and dust particles.

Ideally, this is imperative for firms interested in building trust in products by ensuring their standards meet all safety, quality and health standards.

Inhibits contamination

The processes in clean room injection prevent contamination in its entirety.

Positive pressure involved in this process inhibits non-filtered air from flowing back to the cleanroom via exhaust terminals.

Thus, it ensures air pollutants hardly gather on a small component to affect their ability to function.

Increases Efficiency Of Injection Machine

In clean room injection, airborne contamination is relatively a substantive concern.

However, clean room system solves this issue by carefully controlling direction and air flow rates.

It also regulates temperature, humidity and compression levels, thus enhancing the performance and service lifespan of the equipment.

Cost-effective

Mostly, humidity, static control, air pressure control and latex floor increase performance of a clean room.

All these are vital since they make the entire process affordable while achieving high-quality results.

4.  How ISO Class 7 And ISO Class 8 Clean Room Molding Compare

Ordinarily, clean room injection is available in nine different types or classes.

Class 1 is the most sterile, whereas class 9 is the least sterile.

However, the majority of plastic injection molding in a typical clean room environment occurs in ISO class 7 or class ISO 8 clean rooms.

If you are processing a plastic product with a low tolerance for foreign objects, it would be ideal to go for a more sterile clean room environment.

Here are how these two main clean room classes compare;

• ISO Class 7

It is an enclosed injection molding area separated by hard walls from the rest of the shop floor.

Replacement, cleaning and metering of air in ISO class 7 clean room is constant to keep particulates in line with ISO 14644-1 standard.

ISO 14644-1 standard describes the degree purity of air set by determining the limit values.

ISO Class 7

It can have the following particulates;

a) 352 000 particulate >=.5 micrometer per cubic meter of air

b) 83,200 particulate >= 1 micrometer per cubic meter of air

c) 2,930 particulate >= 5 micrometers per cubic meter of air

ISO class 7 clean room is evaluated and calibrated regularly by a third party agency to ensure it maintains its grade.

• ISO Class 8

Class 8 clean room standards are somewhat less stringent than ISO Class 7 clean room.

The molding equipment used in ISO Class 8 clean room floor is surrounded by movable tenting.

ISO Class 8

Hence, portable air flow is maintained to ensure the particulates are in line with ISO 14644-1 standard.

It can have the following particulates;

a) 3,5200,00 particulate >=.5 micrometer per cubic meter of air

b) 832,000 particulate >= 1 micrometer per cubic meter of air

c) 29,300 particulate >= 5 micrometers per cubic meter of air

5.  How To Make Clean Room Injection Environment

When making a clean room injection surrounding for your business, there is plan you need to execute to guarantee best results.

Here are some of the critical factors to include in your plan;

Designing

Map out your insert molding for your clean room design.

It is advisable to make your clean room as big as you may need it to be since they are getting expensive quite fast.

While at it, figure out whether you’ll be able to mold, assemble and package the product inside the clean room, then determine the ideal space.

Determine The Class

It is important to establish the specific ISO Class clean room you are going to strive for before building.

This is fundamental in deciding on filtration, blower needs, air flow and space.

Calculate Air Flow

Once you have the room size of the clean room, you’ll have to determine the airflow.

Usually, a practical formula to use is;

Needed air flow = Surface X Minimum speed

Get Filtration System

Ensure you go for a specific filtration system with ability to filter at least 99.95% of room particles.

Pick The Structure Material

Ultimately, you need to consider the material you’ll use for building the structure.

Wood is commonly used as a framing component.

The walls are suitable with PVC, plastic or glass.

To ensure the integrity of filtration system stays intact and is never compromised, ensure you seal everything appropriately.

6.  Clean Room Injection Molding Process

The necessity for cleanliness has grown, making the intricacies of clean room injection more complex.

Regulation of cleanliness levels continues to be a growing issue.

However, here is a typical process for a clean room injection molding process;

Product Design

This stage involves developing and designing the particular plastic products intended for clean room injection.

Most manufacturers have in-house designers, but you can as well provide a 2D or 3D drawing of your desired products with tolerance requirements.

Mold Design

It entails use of specific molds designed for particular plastic products.

At this stage, different factors are considered, including cooling systems, materials, and ejection mechanisms among others.

Wall thickness is also customized accordingly to perfection.

Material Selection

Ordinarily, the particular material used in clean room injection influences strength, dimension, tolerance and cost of the products.

Besides, material color is also certificated by relevant agencies; hence a great deal to consider in clean room injection.

Machining

Different manufacturers use various machining techniques in a typical clean room injection environment.

Of course, the most suitable produce the least debris and particles.

CNC machining is quite common since it utilizes computer commands to produce parts or molds.

Moreover, CNC machining is fast and accurate, thus an ideal choice for clean room injection molding.

Molding Method In Clean Room

Primarily, the quality of end product depends significantly on molding technique.

On the other hand, mold quality and precision depend on molding methods.

Thus, it is imperative to determine the specific method to use when picking plastic material.

Secondary Operation

To provide a comprehensive solution on clean room injection products, a wide range of secondary operations are usually integrated.

The specific type of secondary operation on these products depends on injection molding facility and your preference.

Some common secondary operations include the following

• Product assembly
• Sterile packaging
• Ultrasonic bonding
• Pad printing

7.  Environmental Control For Clean Room Injection

Usually, required environments for ISO Class 7 and ISO Class 8 clean rooms need to have lower risk degrees.

To ensure environmental control, numerous checks should be conducted.

Some common checks include; ascertaining instrument’s calibrations, adjusting air flow, air unidirectional, treatment system and air unidirectional check.

The main factors to consider in environmental control for clean room injection include the following;

Positive air flow – To guarantee air purity and maintain a strict particulate count, both ISO class 7 and 8 clean rooms use adequate air flow to ensure a specific particulate matter.

Use of electric machines – It is advisable to use electric machines in place of hydraulic engines in clean room environments to prevent more airborne particles.

Masking requirements – All clean room workers should enter the room with body fully covered, specifically in ISO class 7 clean room.

In ISO class 8 clean room, the coverage requirements less stringent.

Packaging limits – Cardboard or coated plastic packages tend to be common in a clean room environment.

Others like corrugated materials are not allowed in clean room environments since they may produce additional particles.

clean room injection molding

8.  Main Post-Molding Operations In Clean Room Injection

The essence of carrying out most post-molding operations in clean room injection is to enhance the aesthetics of the products.

You can also use such operations to identify and provide directions depending on your preference.

Nonetheless, the main post-molding operations include the following;

Kitting

It is the process of piecing up a wide range of products into a one-ready to use kit.

This operation minimizes need for extra material handling since you will have all your completed assembled products ready for shipping.

If your clean room injection molder performs this operation during manufacturing, it will save you time and money.

Pad Printing

This process entails transferring 2D image to 3D plastic parts.

It requires use of an etched plate and pad to effect image transfer.

You can do printing of various-shaped product surfaces, thus ideal for clean room injection plastic products.

Laser Marking

It uses a laser beam to discolor material surface to black or gray and produce desired graphic or text, but the part remains smooth.

Inkjet Printing

To attain the best result, this process uses a flatbed UV-Led, high-resolution printer to print images on plastic product surfaces.

It can print five different colors simultaneously like a normal paper printer and several parts at a time.

Annealing

This process includes heating plastic products to half the melt temperature in a forced air circulating oven and allowing parts to cool down.

It allows material to relax and reduce molded stress and enhances parts’ stability over time as it increases thermal and mechanical properties.

Annealing comes in handy when a part needs painting since it conceals all the tiniest cracks that would be visible after painting.

Leak Testing

It consists of different techniques for measuring integrity and leak-proofness of a plastic part.

Some methods used in testing leak-proofness include vacuum testing, pressurized gas and pressurized fluid.

9.  Clean Room Injection Molding Assembly Methods

Assembling methods for clean room injection plastic parts are available in four varieties, which include the following;

Mechanical Fastening

It is commonly used when a product requires disassembling for servicing or replacing inner parts.

For more stability, it is advisable to consider metal inserts to guarantee part stability.

Examples of mechanical fasteners include rivets, nuts, screws or pins.

Ultrasonic Welding

This process entails the transmission of sonic pulses to the plastic part using a resonant vibrating tool known as a horn.

The tool uses two plastic materials to vibrate against each other.

It is the vibration that heats and fuses two plastic parts making it a faster technique offering lower cycle times.

Solvent And Adhesive Bonding

It occurs by softening and coating plastic parts using solvents and pressing or clamping them to form a single unit.

On the other hand, adhesive bonding consists of two parts joined by a chemical compound applied to surface of both parts.

Ideally, these two bonding techniques need a solvent or adhesive consumable, and they are relatively affordable.

UV Bonding

It uses ultraviolet curing with high-intensity UV light to cure or dry adhesives.

This technique works well when bonding plastic to non-plastic parts.

10.  Applications Of Clean Room Injection

Clean room injection molding is used in a wide range of applications across different sectors.

Ordinarily, medical industry dominates the use of clean room injection in manufacturing different devices such as the following;

• Surgical instruments
• Cardiac products
• Implantable
• Medical device casings
• Fluid delivery containers
• Emergency room products
• Blood delivery housings

Nevertheless, other industries where use of clean room injection process products are common include;

• Aerospace
• Military
• Food and drink
• Optics
• Biotech

11.  Clean Room Injection Considerations

It is a directive to maintain and regulate clean room protocol, certification and accreditation.

Thus, it is necessary to pay attention to several variables to remain in compliance, such as the following;

a) Procedure documentation, which traces the physical process lifecycle, mold pull cycles and product testing of controlled conditions.

b) Quality control systems like filters and machine hoods monitor, manage and remove particulates and dust likely to cause pollution.

c) Risk management through executing particular analysis modules.

It helps clean injection molders to determine acceptable limits and develop consistent contamination control reviews during manufacturing.

d) Machine operators must entirely commit to procedures within a clean room. They also need to wear protective cloth throughout

e) Work environment controls testing air quality for purity and routine comprehensive instrument checks to determine and address contaminants resulting from production.

12.  Clean Room Injection Quality Control

The primary condition qualifying a clean room for manufacturing plastic parts is obtaining required certifications.

GMP is a system tasked with ensuring consistent manufacturing and control of products comply with quality standards.

It is implemented to minimize production-related risks and covers each element of production process.

Besides, written procedures are correctly detailed and needed for each process to ensure finished product quality is up to required task.

Ideally, such measures ensure quality control is conducted during clean room injection process.

Importantly, clean room injection should be in a controlled environment to ensure plastic materials are not contaminated by dust and other particles.

ISO 13485 is another system designed for an organization dealing with production, servicing and installation of medical devices.

The ISO standards undergo revision every 5 years to keep up with the market demands.

Such practices include regulatory expectations and technological changes.

The newest ISO standard version emphasizes changes related to regulatory demands, risk management and risk-based decision making.

13.  Clean Room Injection Process Risk Management

Risk management in clean room injection process is carried out through implementation of specific modules.

Some of these modules include; Fault Tree Analysis (FTA), Failure Mode and Effect Analysis (FENA) and Hazard Analysis and Critical Control Point (HACCP).

Developing a continuous evaluation to control contamination in manufacturing process allows injection molders to deal with known microbial risks.

Clean room injection molders also identify acceptable limits in manufacturing process.

Some regulated clean room injection products can be harmful to health and wellbeing of users.

Hence, lot of traceability is needed in risk management.

It means that processes involved in clean room injection can be traced to ensure risks are managed.

Lot traceability primarily monitors ingredients, equipment, constituent parts, and labor used in product manufacturing process.

14.  Choosing Clean Room Injection Manufacturer

When looking for an ideal clean room injection manufacturer, it is vital to consider a few critical factors.

Such elements include the following;

• Value-added services

An ideal clean room injection manufacturer should provide a wide range of value-added services.

For instance, welding, sterilization, assembling, packaging and printing among others.

In essence, it is imperative since it implies you are dealing with a manufacturer that can produce products which meet your expectations.

• Experience

It is advisable to choose a manufacturer with a specialty in clean room injection molding for a reasonable duration.

This makes it easier to get the particular products that meet your demands and preference.

• Precision

In clean room injection molding, precision is a fundamental factor you must never overlook.

An ideal manufacturer would ensure they deliver extreme precision using advanced clean room injection systems.

• Product validation

Always work with a company that guarantees rigorous product validation.

Aspects like disinfection, production environment, dimension testing, pressure testing, humidity and cleanliness are vital in this process.

It implies you obtain an entirely assessed high quality, strong and sterile plastic product for your application.

• Fast turnaround time

A reliable clean room injection manufacturer guarantees a quick lead time of molded products using advanced machines.

Therefore, it would be prudent to ensure you get your order within shortest time possible.

• Cost

Ordinarily, the cost of clean room injection products and services often varies from one manufacturer to another.

The cost variance is dependent on a wide range of factors surrounding the production process and final product.

However, it would be important to ensure you get a manufacturer offering cost-effective rates depending on your budget.

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