Millstone Medical works with SencorpWhite’s CeraTek pouch and tray sealers to deliver high quality packaging for top medical manufacturers. SencorpWhite helps Millstone to meet quality requirements, and also provides the documentation Millstone needs for validation. The company’s successful relationship with SencorpWhite allows manufacturers to depend on Millstone for top rate packaging.

“Quality and consistency are paramount to our business,” states Chris Ramsden, CEO of Millstone Medical Outsourcing in Fall River, Massachusetts. Medical device manufacturers are under pressure to deliver quality, innovative products to market as quickly as possible. For 11 years, Millstone has delivered the highest quality packaging for orthopedic and medical device implants. According to Ramsden, “Our customers create high-value implants and depend on us for the highest quality sterile and non-sterile packaging.”

Tray sealer with 24" x 20" usable seal area and 6" deep capacity

Millstone’s post-manufacturing services include advanced mechanical inspection, sterile and non-sterile packaging, loaner kit processing, and warehousing and distribution. Millstone is FDA registered and ISO certified to ISO 13485:2003.

For its pouch and tray sealing equipment, Millstone has standardized on SencorpWhite’s CeraTek pouch and tray sealers. “We have four tray sealers, four pouch sealers, and two gas flush pouch sealers,” says Rick Rose, Sr. Quality Engineer. The tray sealers are CeraTek MD-2420 units with a seal area of 24” x 20”. The pouch sealers are 24-AS/2 and 24-P/2 continuous heat sealers. The two gas flush systems are used for packaging where oxygen is removed from the pouch. Some plastic components do not react well to oxygen, and to ensure quality and long shelf life, the oxygen is removed using an optional evacuation/gas flush system.

“With our gas flush systems, we can consistently achieve oxygen levels below 1%, and in some cases below .25% using purpose-built fixturing,” Rose states.

Benefits from Standardization
Standardization on the CeraTek line provides substantial benefits to Millstone. “It makes it easy for us to train our operators—they get used to seeing the same controls across all our equipment,” explains Brad Schwarz, VP of Operations. “More important, it allows us to cross validate and put different materials on the same type of machine.”

Constant heat pouch sealer with PLC controls and touchscreen operator interface

“Also, over the years we’ve added multiple pieces of equipment,” Ramsden adds. “By standardizing on the CeraTek systems, we can move tooling around and replicate the same results from machine to machine. This has been very valuable for us.”

A Range of Different Materials/Same Consistent Results
Depending on what the OEM requires, pouch materials can include Tyvek/mylar, foil/foil, or different types of nylon. For trays, materials typically are PETG with Tyvek lids. “If we experience any variability in the packaging, 99% of the time, it’s material related, not machine related,” says Ramsden.

Ramsden continues, “Because we are dealing with the top OEMs in the industry, we submit to their quality requirements and quality inspections—so we get looked at very hard by 40 or more different companies each year. We have to produce consistently high-quality packages, no matter what the material.”

SencorpWhite helps Millstone to meet these quality requirements from the moment the new system is ordered. “Every time they quote us a new system, they beat their delivery date. Their tooling is designed and manufactured very fast, and is affordable. If we need modifications we can literally get answers in hours and days, not weeks and months.”

Constant heat pouch sealer with discrete controls

IQ, OQ, PQ, and Validation
SencorpWhite also provides the documentation Millstone needs to get running quickly, and to meet OEM scrutiny. “One of the valuable things that SencorpWhite provides with each sealer is Installation Qualification (IQ) and Operational Qualification (OQ) documentation,” Rose notes. “When we install the system we go through the IQ checklist and then the OQ to make sure the system is functioning properly. At that point we’re ready to bring in packaging materials and run the sealing qualifications (OQ/PQ) to meet each customer’s specific product requirements.”

Responsiveness
“SencorpWhite is exceptionally responsive,” according to Ramsden. “They talked with us when we were small, and in the 6-7 years since our relationship began, we’ve grown 300%. Once, we had water leaking into a system from our low pressure air compressor in our dryer attached to one of the CeraTek systems. Though it wasn’t a problem caused by their equipment, they worked with us through the weekend to get the equipment up and running and keep to our production schedule. They are a great business partner.”

Lynne H. Barton and Kent A. Hevenor are senior account executives at SencorpWhite. They are responsible for the sales and marketing efforts for SencorpWhite's CeraTek product line. Barton can be reached at lbarton@sencorpwhite.com, and Hevenor can be reached at khevenor@sencorpwhite.com.