ISO 7 cleanroom
Cleaning and packaging – HAILTEC: Your partner for precision and purity
In highly sensitive industries such as Medical Technology and other High-tech industries plays Clarity plays a crucial role. With our ISO 7 cleanroom service HAILTEC offers high-precision Cleaning, packaging and labeling processes, which meets the highest standards in terms of Contamination control and Quality Our solutions are designed to keep your components free from contamination while meeting all regulatory requirements to meet.
Many well-known customers from the industry
already trust our expertise
HAILTEC – Your partner for cleanroom services
HAILTEC offers comprehensive cleanroom solutions based on our many years of experience and expertise in cleanroom technology . As a certified company , we guarantee that your products are processed and packaged under controlled conditions to meet the highest quality standards.
- Certifications: Our clean room meets the requirements of ISO 7 classification, which creates a low-particle environment and optimal conditions for the production of Medical devices and other precision components.
- Technological advance: Thanks to state-of-the-art equipment and innovative technologies, HAILTEC offers outstanding solutions for Cleaning, Packing and Laser marking your products.
- Experience and expertise: With many years of experience in Medical Technology and other demanding industries, we are at your side as a reliable partner.
Our ISO 7 cleanroom: Technical details
Our ISO 7 cleanroom meets stringent criteria regarding air purity and particle control . These standards ensure that our processes meet the highest requirements in sensitive industries.
- ISO 7 classification: The ISO 7 cleanroom allows a maximum of 352.000 particles per cubic meterthat are larger than 0,5 µm. This purity level is ideal for the processing and packaging of Medical devices, electronic components and other high-tech components.
- air pollution control: Through state-of-the-art Filter and ventilation systems A constantly clean environment is maintained to prevent any contamination.
- Particle control: Our systems continuously monitor the Particle concentrationto achieve maximum product purity .
Our cleanroom services at a glance
HAILTEC offers a wide range of cleanroom services specifically tailored to the requirements of medical technology and other industries.
Laser marking (including UDI-compliant direct marking)
Our laser marking offers the possibility of permanently marking products – including UDI-compliant direct markings for medical devices . This ensures traceability and compliance with the regulatory requirements of the Medical Device Regulation (MDR).
Cleaning
Our cleaning processes guarantee that your products are absolutely free of contaminants. Cleaning takes place under strict cleanroom conditions to ensure the highest hygiene standards .
passivation
For metallic surfaces, we offer passivation to increase corrosion resistance and improve the longevity of your products. This is particularly crucial for implants and other medical devices.
Packing
Our cleanroom packaging ensures that your products are packaged cleanly and safely for transport and storage. Our packaging materials are specially selected for sensitive industries such as medical technology and electronics .
labeling
In addition, we offer precise and standards-compliant labeling that meets the requirements of the Medical Device Regulation (MDR). We ensure that all products are correctly and clearly labeled.
Perfect interaction of our processes
At HAILTEC, all processes in the ISO 7 cleanroom are perfectly coordinated. This enables seamless manufacturing and packaging, specifically tailored to the material requirements and properties of your products.
- Material variety: Ob Metals, plastics or Special materials – we adapt our processes to the specific properties of the materials to achieve optimal results.
- Long-term tests: We conduct regular Long-term tests through to the Storage and corrosion resistance to ensure our results.
- Flexibility: Our processes are flexible and can be individually adapted to your client requirements be adapted – be it in relation to special Packaging methods or Labeling requirements.
Validated processes and verified results
Our cleanroom processes are validated and guarantee verifiable results at every stage of production. We conduct regular tests to ensure your products meet the highest standards.
- Durability and cleanliness: Our processes have been Storage, corrosion resistance and product purity tested to ensure consistent quality.
- Certified processes: All steps – from cleaning to packaging – are simulation software and can be checked and verified at any time.
UDI guidelines and medical device labeling
The UDI (Unique Device Identification) guidelines are a key component of traceability in medical technology . HAILTEC has extensive experience in implementing these guidelines.
- UDI-compliant direct marking: Our Laser marking offers the possibility to permanent marking of medical devices so that they UDI requirements and the provisions of the MDR correspond.
- Direct Marking (DPM): We offer solutions for the Direct marking (DPM) of components that have a direct Identification and tracking enable – indispensable for the Medical and electronics industry
- labeling: In addition to direct marking, we also undertake the labeling of your products to ensure complete Compliance sure.
Advantages of our cleanroom service
Our ISO 7 cleanroom service offers you numerous benefits that are crucial for medical technology and other industries:
Quality Control
HAILTEC guarantees consistently high quality through validated and certified processes that can be checked and verified at any time.
Compliance with industry standards
Our processes comply with the strictest industry standards and are specifically tailored to the requirements of the medical, electronics and high-tech industries.
Flexibility and process integration
Our services can be flexibly adapted to the needs of your production – from cleaning to packaging to labeling.
UDI-compliant laser marking
We offer UDI-compliant direct marking solutions that comply with the current Medical Device Regulation (MDR).
Maximum product purity
By using our ISO 7 cleanroom, we ensure that your products are manufactured and packaged under optimal conditions.
Game Changers in MedTech: Our cooperation with add'n solutions
Through the partnership with add'n solutions, HAILTEC offers expanded capabilities and additional expertise in the field of medical technology . This collaboration ensures that we can provide our customers with innovative cleanroom solutions and high-tech services of the highest standard.
- Advanced competencies: The combination of our cleanroom services with the expertise of add'n solutions offers you advanced Solutions and Process optimizations.
- Maximum added value: This cooperation enables us to offer you even more efficient and innovative solutions for the MedTech industry offer.
Case Study: One-Stop-Shop Supply Chain for Implants
A leading manufacturer of medical implants commissioned HAILTEC to perform CNC machining, laser cutting, cleaning , UDI-compliant marking , and cleanroom packaging of its products. The implants had to meet the highest hygiene standards while also being reliably traceable.
Solution approach : HAILTEC implemented a specially adapted cleanroom process that comprehensively cleaned, laser-marked and finally packaged the implants.
Result: The customer benefited from a faster time to market and an absolutely reliable traceability its products.
"Thanks to HAILTEC's expertise, we were able to package and label our implants efficiently and in compliance with regulations." – Medical technology manufacturer
Let’s implement your cleanroom projects together!
Contact HAILTEC today for a free consultation regarding your cleanroom projects . Our experts develop customized solutions tailored to your specific requirements. Benefit from our precision , reliability , and innovative strength!
Member of networks and associations
HAILTEC - Your certified partner
FAQ – Frequently asked questions about ISO 7 cleanroom services
What cleanroom services does HAILTEC offer?
We offer comprehensive services such as Laser marking, Cleaning, passivation, Packing and labeling.
What does ISO 7 classification mean?
A ISO 7 cleanroom allows maximum 352.000 particles per cubic meter Air that is larger than 0,5 µm, thus ensuring low-particle environment.
Does HAILTEC offer UDI-compliant labeling?
Yes, we offer UDI-compliant laser markings and Labeling according to the requirements of Medical Device Regulation (MDR)
Which industries benefit from cleanroom services?
Our cleanroom services are ideal for Medical Technology, Electronics, Aerospace and other high-tech industries.
How does HAILTEC ensure the quality of cleanroom processes?
All processes are validated and are regularly tested to ensure consistent quality and purity.
Summary: HAILTEC – Your expert for ISO 7 cleanroom services
HAILTEC, your one-stop job shop, offers comprehensive cleanroom solutions that clean, label, and package your sensitive products to the highest standards. Rely on our experience , innovative strength , and stringent quality standards to implement your projects efficiently and in compliance with regulations. Contact us today for customized cleanroom solutions!