Cleanroom Processing & Packaging
Laser Light manufactures complex and sensitive parts used in everything from electronics to biotechnology plants and even in the human body itself. For that reason, we maintain the highest standards for cleanliness with our cleanroom processing and packaging.
Cleanroom Processing FAQ
- What is a cleanroom environment?
- What are cleanroom requirements for electronics?
- What are cleanroom requirements for the life sciences/biotech?
- What are cleanroom requirements for medical devices?
- What are Laser Light Technologies’ cleanroom facilities like?
- What procedures are in place to avoid contamination of parts? Is there a cleanroom checklist?
- How is quality assurance handled?
What is a cleanroom environment?
A cleanroom is a controlled environment where pollutants such as dust, microbes, and other airborne particles are minimized. Cleanrooms are typically used in scientific research and in manufacturing sensitive products such as microelectronics, pharmaceuticals, and medical devices and equipment.
Keeping the cleanroom environment free from contaminants requires precise control of the area’s air flow, temperature, and humidity, as well as strict cleaning procedures for the people, equipment, and materials that pass in and out of the cleanroom.
Cleanrooms are usually classified into different levels, depending on the amount of “allowed” particles (contaminants) that can exist in the space, conveyed as the number of particles per cubic meter. For example, the outside air that one would find in a typical city environment contains roughly 35,000,000 particles per cubic meter, which includes things like dust, pollen, mold, soot, and car exhaust. This is equivalent to an ISO 9 cleanroom, which is the lowest (baseline) level for a cleanroom.
What are cleanroom requirements for electronics?
The cleanroom concept in microelectronics is one the industry knows well; even the smallest contaminants can seriously degrade the performance of sensitive electronic components, which in turn erodes the value of the product and the bottom line. Contaminated products have been estimated to cost electronics manufacturers hundreds of millions of dollars every year.
Most microelectronics manufacturers require a class 10,000 (ISO 7) or better cleanroom to ensure quality during processing and packaging.
What are cleanroom requirements in the life sciences/biotech?
The standards for cleanrooms used to process products slated for use in biotechnology research and manufacturing applications vary quite a bit, depending on factors such as:
- The end-product being produced in the application,
- The specific part and its placement in the application workflow,
- The potential risks or contamination
Keep in mind that many biotech plants have their own cleanrooms, which must be held to a higher standard.
A global biotech company partnered with Laser Light Technologies to drill a dense array of holes in thousands of filters for bioprocessing containers, a project that also required meeting some challenging production timelines. The parts were laser-drilled and packaged in Laser Light’s cleanroom before shipping.
What are cleanroom requirements for medical devices?
Because many medical devices come into contact with, or are inserted into, the human body, they must be manufactured according to the highest standards of precision and cleanliness. Federal standards, too, play a large role in driving the cleanroom technology and processes needed in medical device manufacturing.
Most medical device manufacturing must be conducted in a cleanroom that is between a Class 100,000 (ISO 8) and a Class 100 (ISO 5). Medical device packaging is typically conducted in an ISO Class 7 or ISO Class 8 cleanroom.
What are Laser Light Technologies’ cleanroom facilities like?
Here at Laser Light Technologies, our cleanroom facilities consist of a 1,100-square-foot ISO Class 5 enclosure, along with multiple ISO Class 7 enclosures. We use these facilities for our proprietary post-process cleaning as well as cleanroom packaging to prevent contamination after manufacturing.
We also maintain compliance with FDA standards by utilizing Class 100 or better laminar flow benches and ionized airflow-assisted packaging.
Our cleanroom facilities are ideal for testing, developing, and assembling highly sensitive parts and products, which themselves are made from materials engineered to deliver very specific physical and chemical characteristics.
What procedures are in place to avoid contamination of parts? Is there a cleanroom checklist?
To ensure the standards of our cleanrooms, Laser Light Technologies has several policies and procedures in place:
Work Area and Personal Attire
The work area, and all personnel in the work area, conform to environmental control standards. People working in our cleanrooms are not allowed to use skin lotions, perfumes, makeup, or powders. All staff entering the work area must wear the environmental “suits” designed specifically for dust-controlled environments.
Cleanroom Shift Procedures
People working in our cleanrooms adhere to a set of procedures designed to maintain our high quality standards, following a cleanroom checklist when coming on or off a shift. Workers are expected to keep their equipment and work area organized and sanitized at all times. When working with products, they are required to inspect parts using either wearable magnifiers or a magnified image projected onto a computer monitor. If any parts do not meet our standards of excellence, they are rejected. All parts are cleaned according to a predetermined process, and strict records are kept to ensure that all processes on the cleanroom checklist have been followed.
Specifications and Standards for Quality Assurance
Our Quality Inspector/Cleaner/Packers are rigorously trained so that they fully understand the specifications of each part, and the standard of excellence demanded by our clients. Employees’ performance is evaluated based on their understanding and rigorous adherence to that standard.
How is quality assurance handled?
Quality assurance is first and foremost the responsibility of a Quality Inspector/Cleaner/Packer. Besides cleaning, inspecting, and packaging parts, these team members are responsible for verifying that all parts conform to required specifications and standards of excellence. They also maintain the records of parts inspected, packed, or rejected, and are responsible for the accuracy of those cleanroom records.
Quality assurance is also subject to regular audits. Laser Light Technologies performs internal, external, and customer audits to ensure effective quality management.
External Audits for Cleanroom Processing and Packaging
For our external audits, ISO 9001:2015 and ISO 13485:2016 are audited separately (different time frames). During an audit, the auditor is provided with access to all areas of the facility, including our cleanrooms. Our external and customer audits have always confirmed high quality, with no major or minor non-conformities or variances.
Internal Audits for Cleanroom Processing and Packaging
For our internal audits, we combine ISO 9001:2015 and ISO 13485:2016 standards. Cross-functional teams with experienced members perform the internal audit, and all team members have completed the auditor training prior to the audit.
Do you have further questions about our cleanroom standards, facilities, or procedures? Visit our contact page.