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Compounding Pharmacies Not All at PAR by Greg Heiland

The generally accepted best practices in both the life science and advanced material market have benefited from years of trial and error, and the best efforts of leading technical/quality colleagues. Marc Stranz, a pharmacist since 1978 and a member of the USP sterile compounding panel, states, “Sterile Compounding Pharmacies are not all at PAR, they have not all figured it out, and it is still too much go-go. The Sterile Compounding Pharmacy market could benefit from collaborating with the standards already developed by IEST and FDA.”

Small pharma

Until the New England Compounding Pharmacy shipped 17,000 vials of contaminated steroid syringes in 2012, triggering a fungal meningitis outbreak which killed 64 people, small pharma was under the radar. Although all licensed pharmacists are trained in basic aseptic technique in pharmacy school from a theoretical perspective, there is a lack of practical knowledge. For example, while the pharmacist was taught about the laminar flow patterns in hoods, (s)he was not instructed in the importance of aseptic operator protocol (i.e. sterile gloves and apparel). The pharmacist was taught the HOW without the much needed WHY base knowledge.

The pharmacist is challenged to perform at the highest level of their license. That is, to fully participate in the clinical care and medical management of the patient. The highest and best value of the pharmacist is not developing and ensuring compliance with the SOP (standard operating procedures) for compounding. Although the pharmacist is technically competent in drug formulation, these competing interests are problematic.

The first standard of any type in small pharma occurred in 1991 with the “Joint Commission,” which focused exclusively on the home infusion subset of the sterile compounding pharmacy market. Although adherence to this new standard was not mandatory, the commercial insurers required accreditation for all home infusion for reimbursement. The financial incentive model was an effective enforcement tool.

It was not until 2004 that the first reference standard was introduced for the whole compounding pharmacy market, USP 797. This unenforceable standard is a diluted version of the FDA cGMP guidance 503. The standard has significant shortcomings, including the omission of requiring sterile apparel and wipers when doing aseptic compounding. There has been a gradual migration to USP 797.

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Pegasus Creates New Videos Filmed at Valutek

Our friends at Pegasus Cleanroom Services provide critical environment cleaning services and information for Biomedical Facilities, Data Centers, Cleanrooms and Electronic Manufacturing Facilities.  The Pegasus team has just updated their online experience by adding a new look and feel to their website. The approach of Pegasus was to make their information easier to find, as well as bringing new information to the table.  The newly created site contains a page of informative videos that were filmed at Valutek’s very own cleanroom.  The videos provide information on everything about proper gowning, cleaning solution preparation and the process of cleaning walls, floors and surfaces.  Look around their new website and let Pegasus know what you think!

Interview With ETH Professor Christofer Hierold About Nanotechnology

Prof. Hierold - Photo: Philippe Neidhart/ETH Zurich

Photo: Philippe Neidhart/ETH Zurich

ETH Zurich Professor Christofer Hierold researches and works with nanotechnology.  ETH, the Swiss Federal Institute of Technology Zurich, conducted an interview with Professor Heirold to discuss the structures, materials and applications of nanotechnology.  Professor Heirold talks about his fascination with nanotechnology, how their specific work in their cleanroom would be hazardous if they did not take proper steps to protect themselves with masks, gloves, etc., and how technology has almost unlimited possibilities.  Click here to read the full interview.

Nanotechnology Degree Programs are Available Due to More and More Companies Utilizing Nanotechnology for Products

More and more universities around the world are starting to offer a degree in nanotechnology.  The increase in companies that utilize nanotechnology to create products, such as pharmaceutical or electronic companies, has brought about awareness of the need for more nanotechnology educational programs.  Ivy Tech Community College in South Bend, Indiana has decided to create a nanotechnology program for students.  Ivy Tech is developing the two year program to prepare students for any technical career that utilizes nanotechnology, such as cleanroom equipment operators or technicians. Click here to read the full article about South Bends developing nanotechnology program.

Pegasus Cleanroom Services E-news

Pegasus Cleanroom Services puts out an informative e-news letter that you can sign up for by clicking here.  This week’s e-news features information on Indoor Environmental Quality, how to keep your business data center running at the most efficient level, and more.  A special offer for 20% off our VTSNTR-99 non woven wiper is also included on this E-news letter.  Click here to view E-news, and don’t forget to sign up for Pegasus Cleanroom Services E-news!

Article notes latex prices have increased 82% over the previous year.

Skyrocketing global prices of latex has influenced one of the world’s leading latex exporting countries to force its domestic customers to look elsewhere.  Selling latex to foreign markets provides larger orders with commitment to buy from these companies despite the drastic annual increase in price.  Click here to read the article.

While the article is interesting, the recent buying behaviors of our clients show this strategy may not work very well. Our clients are buying more synthetic gloves now than ever before. Our clients say the reasons for the change include the potential allergic reactions involved with using latex products along with the rapidly rising cost of latex.  At Valutek, we continue to educate and recommend that our clients purchase synthetic gloves made from Nitrile or PVC.

Rising Latex Prices Impacting Other Industries

The rising costs of raw latex materials is impacting more than just latex glove customers. See how these rising costs are impacting the price customers are paying in another industry. Click here to read more.

In our industry, rising cost is one of many reasons we recomend that our customers use latex alternatives such as Nitrile or PVC.

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