Inspection systems: Page 36

Inspection
FDA Guidance Document addresses sterility issues
If you make a sterile medical product, and you want to avoid sterility testing by instead confirming container and closure system integrity, the Food and Drug Administration has prepared a written Guidance Document just for you. The FDA Guidance Document on the subject has been in draft form since 1998, and was made final in February 2008.
October 22, 2008
Packaging/Filling
On-line printing brings efficiency to Allpack
A new blister-pack line at pharmaceutical contract packaging firm Allpack in Basel, Switzerland, is notable for its use of on-line UV-cured flexo printing of foil lidstock. ...On-line printing of foil lidstock can go a long way toward simplifying inventory and minimizing waste. Just ask Allpack, a pharmaceutical contract packaging firm located near Basel, Switzerland, that handles a variety of human and animal healthcare products.
September 5, 2008
Packaging/Filling
Schwarz powers powder packaging
Asymmetric containers are more problematic for filling than symmetric ones, but they're little problem for Schwarz Pharma. The Seymour, IN-based pharmaceutical products company has packaged its oral solution powders into 4-L (1-gal) offset-neck high-density polyethylene bottles at rates around 20/min for years. Not bad. Yet that wasn't good enough to meet growing demand and future plans. Last year, Schwarz replaced that line to double speeds to 40 bpm, improving changeovers and cleanliness.
August 14, 2008
Package Design
Flexible pouches help medical products maker
It's understandable that medical products company Z-Medica Corp. proudly salutes the 4.5-mil film structure for its line of QuikClot blood-clotting products. After all, the pouch has accommodated several generations of product iterations, and is now targeted for both military operations and consumers such as sports and adventure enthusiasts who may venture far from medical attention. From Versapack , the pouches are shipped premade to Z-Medica three-side-sealed. The pouch is an adhesive lamination of polyester/foil/nylon/polypropylene. The polyester is reverse-printed in four to six colors, depending on the variety.
August 9, 2008
Packaging/Filling
Vitamin maker energizes packaging lines
With private-label customers that include Walgreens, Costco, and Target, and companies with branded products such as those sold at Wal-Mart, expectations run high at Inverness Medical Nutritionals Group, Freehold, NJ. To meet the requirements of these private-label and contract-manufacturing customers, Inverness must maximize efficiency and versatility in its packaging operations. In the past year, the company did just that, adding two identical tablet lines to its 260,000-sq-ft Freehold tablet and capsule manufacturing/packaging facility. Inverness worked with supplier partner Capmatic Ltd. and systems integrator AutoFlex Technology to customize the lines.
June 15, 2008
Iverness Capmatic Auto Flex Private Label Packaging
Inspection
Beating the e-Pedigree deadline
The January 2009 e-Pedigree deadline set by California may have been pushed back two years, but that didn't stop Biogen Idec from forging ahead with a solution. The March 25 decision by the California Board of Pharmacy to push back the state's e-Pedigree deadline to January 1, 2011 (its second two-year delay) gives the overwhelming majority of the pharmaceutical companies in the U.S. new breathing room to meet the anti-counterfeiting measures laid out by the Golden State. But those same foot-draggers are now are at risk for being awarded the Black Hat worn by bad guys. That allows the small handful of companies who have solved the packaging serialization puzzle to claim the competitive and public relations benefits that come to those who wear the White Hats.
June 15, 2008
Packaging/Filling
Bottle containment filler plays it safe
When packaging operations for Abilify, a drug to treat schizophrenia, and Coumadin, a blood thinner, were transferred to a different plant, Bristol-Myers Squibb decided to install a new bottle containment filling line. The goal was to improve fill accuracy and protect workers from the products' dust. New Brunswick, NJ-based Bristol-Myers Squibb researched different fillers on the market and chose the Model 815 15-wheel bottle filler from Aylward Enterprises. This story describes Bristol-Myers Squibb's Mt. Vernon, IN, facility's employment of a restricted access barrier system to protect workers from high-potency drugs.
April 15, 2008
Inspection
Metal detector with multifrequency technology
Software helps track medical devices and biologics from manufacturer to patient.
April 15, 2008
Packaging/Filling
Medical device packaging training track at MD&M West conference
A medical device packaging track chaired by Randall Troutman (shown in photo), CPP, Oliver Medical Products, will take place from 9 a.m. to 4 p.m. Monday, Jan. 28, during the MD&M (Medical Design & Manufacturing) West Conference at the Anaheim Convention Center, Anaheim, CA. MD&M will be co-located with six other manufacturing shows at WestPack.
January 22, 2008
Package Design
Medical device blogger addresses technical questions
Validating heat sealers, dye penetration and burst tests, the consequences of designing packaging late in the product design process, and sterilization issues are among the topics that Jacob Kearns has answered in the past year on his "Medical Device Blog." Kearns is an engineer for a medical device company. Differing points of view may be shared on this blog.
January 9, 2008
Packaging/Filling
Brecon betters blister packing
Nowhere in packaging are flexibility and fast changeover more necessary than in the contract-packaging arena, where multiple customers and their many SKUs are a fact of life. That’s why ease of changeover was a key machine characteristic sought by Brecon Pharmaceuticals recently when it came time to install a new line for blister packing and cartoning of tablets. This fast-growing contract packager, acquired last year by Amerisource Bergen, is located in the UK near the town of Brecon, Wales. Both thermoforming and cold-forming of foil are routinely done on this new and highly versatile blister-pack line.
October 29, 2007
Package Design
Operating room personnel input critical to new peelable chevron header pouch
A nurse/doctor forum convened by Rollprint earlier in the year served as the catalyst for the company's new Duet functional peelable chevron header pouch. Designed to ease pouch access and improve aseptic presentation, the new-generation pouch was developed after operating room physicians and nurses from the Austin, TX, area participated in a packaging focus group. The intent was to glean insight into the pros and cons of existing sterile medical packaging and to better understand what innovative design improvements would help healthcare workers better perform their jobs.
October 16, 2007
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