Clean Room Injection Molding Manufacturer with One-stop Service

Professional Clean room Injection Mold Manufacturer

Clean room injection molding is widely used in many industries such as optics, electronics, precision manufacturing, medicine and health care and so on. The clean room for injection molding varies greatly according to the precision requirements of the industry and the production process, and the level of purification needs to be analyzed on a case-by-case basis. Kemal cooperates with many research and medical institutions and has a wealth of practical experience to produce products that meet the standards If you are looking for a clean room injection mold partner, email or call us right now to get the nice price.

Clean Room Injection Molding Parts

Kemal cleanroom has cutting-edge mold manufacturing equipment, such as high-speed CNC, precision wire EDM, precision EDM machine, etc, these equipment are the strict guarantee of precision in molding.

we are capable of offering tailor-made products which include medical parts, bottle caps, and pharmaceutical parts.

Why choose Kemal Make Clean Room Injection Molds

Kemal’s cleanroom injection molding and manufacturing operation has a total area of 800 square meters and is certified to a dedicated Class 8 standard and follows good manufacturing practices. meanwhile, the cleanroom is temperature and pressure controlled and can also be used for decorative assembly and packaging of parts.

we set up a special management team to monitor and maintain the clean injection molding room.

Through strict and systematic training, make the system process to meet your time needs.

This is a strong guarantee for the success of your future projects, Kemal can be counted on for your trust.

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Kemal Your Trusty Clean Room Injection Molding Manufacturer

Kemal strictly implements the ISO9001 quality system and equipped with advanced cleanroom injection molding machines with specialized processors. these machines have special handling systems that guarantee dust-free quality and high-performance standards in a constant temperature and humidity environment.

Kemal also has a team of professionals who can shape, assemble, and package your products in our clean room environment. This not only ensures that your part stays clean, but also frees up your time to focus on marketing and sales.

The cleanroom injection molding workshop is mainly used in medical, optical, electronics, and other industries.

Contact us today, Kemal is your value-added cleanroom injection, molding partner.

More Questions You May Ask

What's clean room Injection molders must pay strict attention to?

(1) Quality control systems.

(2) Procedure document.

(3) Work environment

(4) Risk management.

(5) Operators training

What service do Kemal offer when one customer request clean room injection molding?

(1) Product Design

(2) Design Review (DFM/mold flow analysis, tolerance analysis, feasibility studies)

(3) 3D printing or prototype molds

(4) Mold build.

(5) Injection molding

(6) Massive production

(7) Tool maintenance.

(8) Technical support and services.

What’s the standard for the clean room injection molding of Kemal?

(1) Scientific molding

(2) Strict tolerances.

(3) Flame retardants.

(4) Anti-fouling.

(5) Anti-static.

(6) Anti-slip.

(7) Anti-microbials.

(8) Anti-oxidants.

(9) Compressed air filtration system.

(10) Vacuum bag sealer.

What is the construction material for the workshop of clean room Injection ?

The material of the walls and roof of the injection cleanroom is generally made of 50mm thick sandwich color steel plate and special purified alumina profile. Doors are purified and sealed, and windows are made of aluminum alloy glass. The floor is made of epoxy self-leveling or high-grade wear-resistant plastic dust-free floor. The ventilation ducts are made of galvanized thin steel plates, and the “PEF” flame retardant heat preservation board is used for insulation.

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CLEAN ROOM INJECTION MOLDING: THE ULTIMATE FAQ GUIDE

As a professional the Clean Room Injection Molding manufacturer with 24 years experience. Kemal pays 100% passion to serve you well.
Here is the FAQ list of the Clean Room Injection Molding. You could check any question about the Clean Room Injection Molding that you would like to know. Such as:
What is Clean room Injection Molding?
What are the requirements of clean room injection molding?
What is Kemal’s standard of clean room injection molding?
For further communication just feel free to Contact Kemal Team.

1. What products are the Clean Room Injection Molding process typically
used in?
2. What is the composition of the Clean Room Injection Molding Room?
3. What are the main factors that affect the cleanliness of a cleanroom (area)?
4. How to clean, disinfect, and sterilize the Clean Room (area)?
5. What are common defects in the production of the medical syringe when using the Clean Room?
6. What are the characteristics of the clean rooms in the Electronics Manufacturing Industry?
7. What are the basic features of biopharmaceutical clean rooms?
8. What are the requirements of the Drug Packaging Clean Room Workshop?
9. What is Clean room Injection Molding?
10. What are the requirements of clean room injection molding?
11. What is Kemal’s standard of clean room injection molding?
12. What service do Kemal offer when one customer request clean room injection molding?
13. What’s clean room Injection molders must pay strict attention to?
14. What kind of medical products need to use medical clean room injection molding?
15. What kind of plastic materials usually use in the medical clean room injection molding?
16. What is the Clean room consideration?
17. What is the clean room classification?
18. How to Maintain Clean Room Standards?
19. Do You want to ensure smooth serial production of high-end injection molded parts under clean production conditions?
20. Why Choose Kemal as the clean room injection molding Supplier?

1.What products are the Clean Room Injection Molding process typically used in?

Clean Room Injection Molding process typically used in the industry as below:
1) Electronics Manufacturing.
2) Pharmaceutical packaging.
3) Medical Plastic Product Manufacturing.
4) Automotive manufacturing.

 

2.What is the composition of the Clean Room Injection Molding Room?

Generally speaking, the clean room (area) refers to the working environment required for the production and inspection of Medical Devices.
For the production, it should include the function room corresponding to the production process, such as the injection room, the drying room, etc.
It should include functional rooms related to testing, such as positive control rooms, sterile rooms, and microbial limit rooms; auxiliary functional rooms for production, such as laundry rooms, sanitary warerooms, etc. And buffer transition channels connecting the various functions.

3.What are the main factors that affect the cleanliness of a clean room (area)?

1) Characteristics of medical devices.
2) Production Technology of the medical instruments.
3) Personnel, facilities, sanitary requirements, the appliance.
4) The atmospheric environment.

 

4. How to clean, disinfect, and sterilize the Clean Room (area)?

The common surface disinfection and sterilization methods are ultraviolet lamp irradiation, ozone contact, gas fumigation such as peroxy hexanoic acid, oxirane, and disinfectant spraying.
Disinfection and sterilization is the main method to drive away microbial pollution, however, It is necessary to ensure the thoroughness of disinfection and sterilization, so the production enterprises must formulate disinfection and sterilization procedures, and periodically to verify its effectiveness.

 

5.What are the common defects in the production of the medical syringe when using the Clean Room?

When using the Clean Room, the common defects in the production of the medical syringe are as below:
Shrinkage, White mark, Wave mark, Flash, and other defects are easy to appear on the surface of the medical syringe needle sleeve.

6.What are the characteristics of the clean rooms in the Electronics Manufacturing Industry?

The characteristics of the clean room in the Electronics Manufacturing Industry are as below:
1)Clean rooms of the electronic manufacturing industry have extremely strict requirements on static electricity, especially on humidity.

In general, the temperature of the electronic workshop should be controlled around 22, and the relative humidity should be controlled between 50-60% (special clean workshops have relevant provisions on temperature and humidity).

Because it is easy to generate static electricity in the excessively dry workshop, resulting in CMOS integration damage.

2)Noise level (empty state) in class 10,000 clean room in electronic manufacturing plants: not greater than 65 DB (a).
3)Electronic manufacturing plant clean room vertical flow clean room fill ratio should not be less than 60%, horizontal one-way flow clean room should not be less than 40%,  otherwise, it is a local one-way flow.
4)The static pressure difference between clean room and outdoor.it should not be less than 10Pa, and the static pressure difference between clean area and non-clean area with different air cleanliness should not be less than 5Pa.

 

7.What are the basic features of biopharmaceutical clean rooms?

The basic features of a biopharmaceutical Clean Room Injection Molding Room are as below:

1) The decontamination room of biopharmaceutical must take the dust particle and
the microorganism as the Environment Control Object.

2) There are four levels of shop cleanliness: 100 or 10,000, local 100,1000,10,000, and 30,000.

3) The Clean Room Temperature: without special requirements, in 18 ~ 26 degrees, the relative humidity control in 45% ~ 65%.

4) Pollution Control in the clean workshop of biopharmaceutical industry: Pollution Source Control, dispersion process control, cross-contamination control.

5) The key technologies in the clean room of the biopharmaceutical industry are mainly to control dust and microorganisms as pollutants, the microorganism is the most important part of environmental control in the clean room.

 

8.What are the requirements of the Drug Packaging Clean Room Workshop?

The requirements of the Drug Packaging Clean Room Workshop are as below:

1)Provide the required air purification level for production, The number of air dust particles and living microorganisms in the purification engineering of packaging workshop should be regularly tested and recorded. The static pressure difference between different classes of packing shop should be kept within the specified value.

2)The temperature and relative humidity of the packaging workshop purification project shall be appropriate to the production process requirements.

3)The production area of penicillin, highly allergenic, and antineoplastic drugs should be equipped with an independent air-conditioning system, and the exhaust gas should be purified.

4)For the dust room,It should be set up effective dust catching device to prevent cross-contamination of dust.

5)For For auxiliary production rooms such as storage, ventilation facilities, temperature, and humidity should meet the requirements of drug production and packaging.

9.What is Clean room Injection Molding?

Clean room molding is the process of creating plastic parts in a special room optimized to reduce the risk of contamination by dust or other particles.
Clean Room molding is widely used in the field of the medical, pharmaceutical, aerospace, military, and biotechnology industries.
There are nine “classes” of clean rooms, with class 1being the most sterile, and class 9being the least sterile. Most plastic injection molding in a clean room takes place in either a class 7or a Class 8clean room. It’s the standard you’ll need for any portable device.

10. What are the requirements of clean room injection molding?

Positive airflow:
To ensure the purity of the air and to maintain a strict environment with the particulate count, both class 7 and class 8 clean room for injection molding uses positive airflow to ensure a specific particulate matter.
Wearing protective clothing:
Clean rooms injection molding are restricted areas and access must only be allowed to authorized persons who enter the clean room fully covered—including shoe covers, full protective clothing, and hair covers. And all clothing must be changed immediately after becoming contaminated.
Electric machines:
To avoid more particulates in the air, electric machines replace hydraulic machines in the clean room injection molding environments.
Packaging requirements :
Packaging of certain corrugated materials will produce additional particulates, so will not allow in clean rooms. coated cardboard or plastic packaging is most common.
Kemal’s clean room is used for a wide range of custom molding applications for more than 20 years, and strict to meet the demands of industries requiring ISO 14644. specifically for medical parts that require compliance to ISO 13485 standards. also provides a competitive advantage for clean room molded plastics through engineering phases, such as product design, project management, mold building, material selection, and product test.

11.What is Kemal’s standard of clean room injection molding?

The standard of clean room injection molding is as below:
Scientific molding method
Tight tolerances
Flame retardants
Anti-fouling
Anti-static
Anti-slip
Anti-microbials
Anti-oxidants
The compressed air filtration system
Vacuum bag sealer

12.What service do Kemal offer when one customer request clean room injection molding?

1)Product Design
2)Design Review (DFM/mold flow analysis, tolerance analysis, feasibility studies)
3)3D printing or prototype molds
4)Mold build.
5)Injection molding
6)Massive production
7)Tool maintenance.
8) Technical support and services.

 

13. What’s clean room Injection molders must pay strict attention to?

The clean room Injection molders must pay strict attention to that:
1) Quality control systems.

2) Procedure documentation.

3) Work environment

4) Risk management.

5) Operators training

14.What kind of medical products need to use medical clean room injection molding?

The medical parts that need to use medical clean room injection molding are as below:
1) Medical device housings
2) Surgical instruments
3) Implantables
4) Emergency room products
5) Fluid delivery devices
6) Fluid delivery containers
7) Cardiac products
8) Blood delivery housings
9) Optical grade lenses
10) Dental products
11) Medical device housings
12) Surgical Instruments
13) Emergency plantable
14) Fluid delivery devices
15) Fluid delivery containers
16) Cardiac products

15.What kind of plastics materials usually use in the medical clean room injection molding?

The plastic materials usually use in the medical clean room injection molding are as below.
1)PC/ABS
2)ABS
3)Acetal
4)HDPE
5)LDPE Nylons
6)TPE

16.What is the Clean room consideration?

1)Quality control systems, such as HEPA filters and machine hoods, that monitor, manage,
and remove particulates and dust that could otherwise cause the requisite number of pollution particles to fall out of specification for ISO 7 and ISO 8 clean room standards.
2)Procedure documentation that physically traces the process lifecycle, mold pull cycles,
and equipment/product testing so verification of controlled conditions is readily available in the event of repeated cycles, routine checks, customer requests, or procedural deviations.
3)Work environment controls that test air quality for purity and routine, comprehensive equipment checks to find and address contaminants that result from production — like particulates from ejected parts, peeled or shaved undercuts, and microscopic plastic parts. Further, machine maintenance can introduce contaminants if not done properly.
Over-greasing components, for example, can be particularly detrimental.
4)Maintenance can introduce contacts if not done properly. Over-greasing components, for example, can be particularly detaching.
5)Risk management through implementing specific analysis modules like fault tree analysis (FTA), failure mode and effect analysis (FEMA), and hazard analysis and a critical control point (HACCP). Knowing and evaluating the microbial risks helps injection molders identify acceptable limits and develop consistent contamination control assessment during manufacturing.
6)Requirements traceability for FDA-regulated implantable medical products that are intended to remain in the human body in excess of one year, non-implanted, life-supporting devices used outside of medical facilities, and all other complex applications whose failure would also likely have serious, adverse health consequences.
7)Machine operators must fully commit to the procedures within a clean room, as cutting corners is unacceptable. Plus, they must strictly adhere to wearing protective gear like gloves, gowns, masks, and booties to protect clean room environments and the injection molded parts and components from contamination.

17.What is the clean room classification?

In addition to ISO and CFR standards, clean room injection molding environments are classified, typically into ISO 7 or ISO 8.
Certification for the former verifies that the clean room contains 10,000 pollution particles per cubic foot, and the latter means the clean room is certified to 100,000 pollution particles per cubic foot. The type of clean room used for manufacturing is dictated by a specific product and/or customer requirements.

18.How to Maintain Clean Room Standards?

Complex medical applications require devices and equipment that are protected from dust, chemical vapors, aerosol particles, airborne microbes, and other contaminants that could compromise product quality, integrity, and safety.
Responsible injection molders providing services to medical manufacturers are obligated to adhere to stringent protocols.
Beyond operating in clean rooms that are ISO 13485:2016-certified and 21 CFR 820-compliant (the prevailing standards for ongoing quality).
MedAccred accreditation assures medical OEMs of an unparalleled benchmark of production and quality standards.

19.Do You want to ensure smooth serial production of high-end injection molded parts under clean production conditions?

If you want the Clean room Injection Moulding Service, Kemal offers the corresponding clean-room solutions:
Only first-rate: from the stand-alone machine to the fully automated turnkey system All from an expert source. Either directly for your clean room, docked with the clean area, or as an individual clean-room cell. Cutting-edge technology and in-depth expertise from Kemal working hand-in-hand.
That is clean-room production which leaves nothing to be desired.

 

20.Why Choose Kemal as the clean room injection molding Supplier?

Standards and guidelines
Protect injection molded parts from air-borne contamination such as dust particles, bacteria, or viruses? For this purpose, negative influences arising during production need to be limited and prevented from coming into contact with the product. In practice, this can be achieved through high-quality ventilation

And air conditioning for example. The central set of regulations for defining clean rooms is the EN ISO 14644 standard. This can be supplemented by further EN ISO, VDI, and VDA standards, the specifications of the GMP (Good Manufacturing Practice), directives from the European Union and US FDA (Federal Drug Administration) as well as individual specifications and corporate standards.

Qualified and validated

We offer comprehensive qualification documentation for all-rounders in order to meet the requirements for ISO 13485 and GMP. It encompasses standard machine configuration,
operating manual, functions descriptions, maintenance intervals, cleaning instructions, spare parts lists, set up plans, and circuit diagrams. The inspection logbook as a certification for the machine capability can be included if necessary. In order to maintain the reproducibility of an injection molding machine, you can close a service contract with us which ensures a regularly qualified re-validation.

Essential: clean operation
Regular cleaning and disinfection of the clean room and all production facilities are essential if a clean production environment is to be maintained. We provide injection molding technology that is easy to clean and that makes operation correspondingly efficient. In addition, specific hygiene measures for personnel are decisive as well. Special work clothing and working guidelines (cleaning procedures before and after working in the clean room) are required with no exceptions.