In today's competitive market, many outsourcing companies claim to run top-of-the-line cleanroom facilities for packaging sterile medical devices. But not all cleanrooms are the same.

It is important to understand that fundamental differences exist between cleanrooms for medical device manufacturers and cleanrooms for manufacturers of machinery, optical products, high-end electronics, and other devices not intended to penetrate the skin or interact with open wounds. Medical OEMs that produce orthopedic or spinal implant technologies, for example, require cleanrooms that demonstrate extremely low bioburden rates as well as those that can restrict airborne particles. Airborne particles are the enemy of hard drives and microchips, whereas both particles and microorganisms pose a threat to medical devices.

Medical device OEMs need cleanrooms that have an established platform of technology and biocontamination protocols that extend through component preparation, product assembly, packaging, and testing of sterile medical devices and surgical products.

Since quality is a key factor in the success or failure of many medical device manufacturers, how does a medical device maker search out a facility that packages a product to current rigorous standards? This article presents 10 questions that medical device manufacturers should ask potential partners and themselves when choosing a cleanroom service provider.

1. Does the Cleanroom Actually Exist, or Is It Simply a Marked-Off Area?

Many outsourcing companies recognize the value of cleanroom services to their customers. However, some have not invested the time, attention, and financial resources necessary to build a cleanroom facility that meets the sterilization standards required by medical device manufacturers. Cleanrooms must be constructed with the proper components in order to meet these standards. These components include a separate air-conditioning system and sealed, particle-free ceiling tiles. Also important are plenum grids that enable proper placement of HEPA filtration units at optimal locations as well as hollow-wall air returns that allow previously cleaned air to be recycled. Such returns extend the life of the HEPA filters cleaning the air.

2. Is the Cleanroom Fully Integrated into the Quality System?

The integration should include comprehensive corrective and preventive action protocols to thoroughly address all cleanroom excursions. Outsourcers have a responsibility to their customers to measure, track, and realign any potentially harmful conditions in the cleanroom. Outsourcing companies that take this responsibility seriously are always on the lookout for opportunities to improve their cleanroom systems.

3. Does the Cleanroom's Layout Promote Efficiency and Reduce Biocontamination?

A well-conceived cleanroom layout, including placement of workstations and machines in relation to walls, enables air to move with uniform velocity and along parallel flow lines, also known as laminar flow. Laminar flow reduces turbulence, which in turn reduces particle production and the introduction of microorganisms. OEMs should seek out packaging partners that consider airflow concerns as well as production capacity when designing their cleanroom footprint.

4. Is Cleanroom Maintenance a Priority?

It sounds obvious, but it bears repeating that a cleanroom is only as good as it is clean. Contamination, in the form of particles and microorganisms, can come from spills and leaks, employees' skin and clothing, cleaning chemicals and debris, and other outside agents. Many providers of cleanroom packaging services build state-of-the-art facilities that could conceivably address the sterilization requirements of medical device manufacturers. But such cleanrooms cannot consistently prevent the contamination of an end product if they are not maintained with strict protocols. In addition to using proper cleaning procedures, outsourcing partners should use only cleaning products, from disinfecting solutions to tools, that are certified for use inside cleanrooms.

5. Is a Validated Ultrasonic Clean Line Attached to the Cleanroom?

When a product arrives at an outsourcing company's facility, it is just beginning its journey through a minefield of opportunities for contamination. Without an ultrasonic clean line to give products the once-over before they enter the cleanroom, products bring with them all the biohazards they have picked up along the way. The end result is increased bioburden within the cleanroom and increased risk of product contamination. Companies without clean lines attached to their cleanrooms are often forced to clean products in the machine shop before the products go through processes like receiving, inspection, and etching. With cleaning as the last step before the product enters the cleanroom, much of the variability is removed. The chances of bioburden spikes are limited to the packaging process, which is the easiest to control because it occurs within the cleanroom.

6. Has the Cleanroom Been Audited Multiple Times?

Outsourcers should welcome audits, as painful as they might be. They should accept audits from any source, including clients, FDA, and ISO registrars. Audits should be seen as opportunities to consider an objective view of a company's cleanroom policies and procedures and a possibility to enhance the sterility of its cleanroom facility.

7. Is the Cleanroom Staffed with Experienced Sterile Packaging Technicians?

There are at least three ways cleanroom personnel can affect bioburden levels in a sterile environment. Those ways include what they wear, how they behave, and how they help maintain cleanroom protocols. People in general are a leading dissemination source of particles and microorganisms through their hair, skin, clothing, cosmetics and perfume, and respiratory emissions. Cleanroom specialists are trained to limit cosmetics and perfumes and to wear garments appropriate for specific cleanroom standards, such as gowns, caps, shoe coverings, gloves, and even face masks. Behavioral requirements, including rate of movement, minimize the transfer of microorganisms and particles.

8. Is Testing Paramount?

Even with all the necessary pieces in place, a cleanroom can be a toxic environment if a system breaks down. Outsourcers that use testing to remain vigilant can assure their clients that products meet the highest sterilization standards. Tests that should be performed quarterly include testing of bioburden levels, such as microbial air and surface tests, and dose audits to ensure that products meet validation specifications.

9. Does the Cleanroom Run a Particulate-Monitoring System?

Some outsourcers measure particulate levels every minute at each workstation using a particulate-monitoring system (PMS). This additional testing provides the proof that products were packaged within acceptable particulate levels and provides an opportunity to correct an excursion issue before products ship out. A PMS can provide tight real-time monitoring and control.

10. Do I Trust This Company?

To provide its OEM partners with packaged medical devices that come as close as possible to sterilized perfection, an outsourcing company must meticulously plan and construct a cleanroom, establish an interrelated set of protocols, and adhere to strict guidelines. Trusting that an outsourcing partner has the expertise and integrity necessary to run an effective cleanroom can be a tall order for OEMs. There are many opportunities for error throughout the process, and every product that clears the sterile packaging process and is then distributed has the potential to aid or to harm a patient. A single product recall that results from compromised sterility of an improperly packaged device can be catastrophic, in terms of both potential patient risk and the OEM's financial survival.