Cleanroom Packaging Services
Semiconductor – Aerospace – Medical
Our state-of-the-art ISO 7 (Class 10,000) Cleanroom facility allows us to custom manufacture, fabricate and assemble foam inserts and packaging solutions. We specialize in creating custom designed packaging for the semiconductor, aerospace and medical industries with technical and environmental compliance.
Certified Clean Room
Our state-of-the-art on-site facility manufactures ISO 7 (Class 10,000) Cleanroom certified packaging. It is the only one of its kind in the State of Arizona, and one of a few in the western United States. Within our new facility we fabricate custom foam inserts, fully assembled cleanroom packs and packaging solutions used for shipping intricate, sensitive and critical items for the semiconductor, aerospace and medical equipment industries.
The cleanroom is tested annually and is certified per ISO 14644-1 Standard. A copy of the Certification is available upon request. Our certified technicians oversee the operational efficiency of our HEPA filters using a Kanomax Handheld Particle Counter to monitor and ensure airborne particulates remain within compliance of ISO 7 cleanroom requirements. This process ensures the quality of our products not only meet but exceed all our clients’ cleanroom needs at all time.
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Protective Packaging Solutions For Electronic Components
With over 50 years of experience and expertise in the foam packaging industry Foam Packaging Specialties is a trusted leader in the design and manufacturing of packaging solutions and is uniquely qualified to create custom cleanroom packaging for any product or industry.
Delivering The Highest Standards in Design & Production
Our cleanroom packaging services include design, engineering, die-cutting, laminating, sheeting and assembly. This refined process allows our team of in-house experts to deliver industry leading solutions with award winning customer service. Our short lead times reduce customer material and labor investments while maintaining the highest levels of quality control.
ISO 7 Cleanroom
CLASS ISO 7 – FEDERAL 209E STANDARD CLASS 10,000
Our new ISO 7 clean room (Class 10,000 cleanroom) is a hard-sided wall manufacturing facility that utilizes HEPA filtration systems to maintain air cleanliness levels lower than the 10,000 particles (≥0.5µm) per cubic foot standard. Our Class 10,000 cleanroom filtration system provides filter coverage of 15-25% and – a minimum of 60 air changes per hour. We exceed the standard air flow rate for an ISO 7 filtration system of 9-16 CFM per square foot.
ISO 7 Cleanroom Standards
Classification for cleanrooms ranges from ISO 1 to ISO 9, with ISO 9 being the “dirtiest” and ISO 1 being the “cleanest.” These classifications are assigned based on the maximum allowable concentration of particles per cubic foot or meter of air. ISO class 7 clean rooms were previously defined under US Federal Standard 209E but are now defined under ISO 14644-1, however, both are still regularly used as reference points.
- US Federal Standard 209E: denotes the number of particles (≥0.5 µm or larger) per cubic foot (f³) of air.
- ISO 14644-1: replaced federal standard 209E in 2001 but is still used as a reference. It denotes the number of particles (≥0.1µm to ≥5µm or more) per cubic meter (m³) of air.
ISO 14644-1 Standard for Maximum Number of Particles Permitted/m³ for ISO 7 Cleanrooms
(FED STD 209E Equivalent: Class 10,000)
|≥0.1 µm||≥0.2 µm||≥0.3 µm||≥0.5µm||≥1µm||≥5 µm|
US FED Standard 209E Maximum Number of Particles Permitted/ft³ for Class 10,000 Cleanrooms
(ISO 14644-1 Equivalent ISO 7)
|≥0.1 µm||≥0.2 µm||≥0.3 µm||≥0.5µm||≥5 µm|
ISO 7 Cleanroom Protective Requirements
Our Class 10,000 cleanroom requires workers to wear fewer protective garments than cleanrooms with a lower classification but still require the use of cleanroom clothing such as face masks, hair covers, gloves and lab coats or other frocks to cover street clothing. Our Cleanroom clothing is made from non-woven fabrics to prevent contamination from shedding material fibers. Gloves are sterile and made from latex, nitrile or other synthetic materials.
Depending on your industry and application requirements, other precautionary measures may be taken to control particle count in our ISO 7 cleanroom environment. Sticky mats are placed outside of cleanroom entrances to remove dirt and other contaminants from shoes. Pass-thru cabinets fitted with filtration systems are used to safely transfer products while limiting the number of people entering and exiting the room.
We found Cleanroom requirements vary widely based on industry standards and the type of processes being performed. Consult with our cleanroom professional for assistance in selecting the design and classification that are best suited for your application.
Common ISO 7 Clean Room Requirements Include:
- Product pass thru’s
- HEPA fan filters
- Heat welded vinyl or epoxy floors
- Gowning atrium
- Air locks
- Air conditioners
- Entrance and exit sticky mats
- Sealed lighting
- Bunny suit, booties, gloves and hair cover
Our custom foam packaging solutions are your products best friend. Contact us today and let’s talk foam!
Does the Cleanroom’s Layout Promote Efficiency and Reduce Biocontamination?
When we designed and constructed our ISO 7 Cleanroom (class 10,000) we utilized a well-conceived layout which enables air to move with uniform velocity and along parallel flow lines. We carefully designed and placed our workstations and machines in relation to the walls to achieve laminar flow. This reduces turbulence, which allows for the reduction of particle production and the introduction of microrganisms.
is the cleanroom fully integrated into the quality system?
At Foam Packaging Specialties we have implemented comprehensive corrective and preventative action protocols that address all cleanroom issues and the opportunity to improve the cleanroom system. This includes a written plan that covers maintenence of the cleanroom and technician training. We regularly calibrate our equipment that measures cleanroom contaminants and that information is then recorded in a log.
Is a Validated Ultrasonic Clean Line Attached to the Cleanroom?
Our cleanroom uses an ultrasonic clean line on products before they enter the cleanroom. This removes much of the variability and chances of bioburden spikes are limited to the packaging process, which is easier to control because it takes place in the cleanroom.
Has the Cleanroom Been Audited Multiple Times?
Foam Packaging Specialties welcomes audits of every type ranging from clients to ISO registrars. Over the past five decades we have demonstrated our expertise in foam packaging and have a continued willingness to learn which has allowed us to further refine our practices with our cleanroom services. We are always reviewing our policies and procedures to enhance the sterility of our cleanroom facility.
IS THE CLEANROOM STAFFED WITH EXPERIENCED STERILE PACKAGING TECHNICIANS?
Our in-house staff is very experienced and understand that they can be the leading source of contamination in the cleanroom if they don’t follow the proper protocols. Our cleanroom specialists are trained in behavioral requirements and cleaning procedures required for facility maintenance to minimize the transfer of microorganisms and particles.
Does the Cleanroom Run a Particulate-Monitoring System?
We employ a particulate monitoring system in our cleanroom that measures particulate levels in the room. We believe this extra level of testing ensures that products are packaged within acceptable particulate levels which allows for excursion correction before the product leaves the facility. This monitoring system allows us to make adjustments in real time if particulate levels rise so our packages always meet the OEM’s quality inspections.