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
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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

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.

Want a Live Peek Inside one of NASA’s Cleanrooms?

Here in the Valutek office, we’ve made a fascinating discovery – a live feed from NASA’s Jet Propulsion Laboratory, where technicians are working on the next Mars rover, dubbed “Curiosity.”

Today, around noon, about 12 technicians crowded around the vehicle, taking photos, discussing important things (we assume, maybe they were making lunch plans) and inspecting parts. They were of course sporting cleanroom apparel, including coveralls, hoods, booties and face masks.

The Web site that features the live feed explains, “Technicians assembling and testing the Mars Science Laboratory, aka Curiosity, are covered head-to-toe in “bunny suits.” These white smocks, booties and facemasks help protect against Earthly contaminants hitching a ride to Mars.” The site also features videos explaining how the rover is made, how it navigates and other interesting facts about their work.

The site was presumably designed for school children, to stimulate their interest in space and science, but we think it’s pretty cool, too! Have a look at the live feed of the NASA cleanroom for yourself by clicking here.

With our own “Curiosity” now piqued, we searched for other controlled environments willing to let anyone with an Internet connection watch their technicians work. And we came across the University of Alberta’s Nano Fab.

This site really lets your inner voyeur have fun by providing a floor plan of their cleanroom, including the Gowning and Inspection rooms, and Sputtering and Bonding areas. Simply click on your room of choice, and viola! We caught a glimpse of some operators changing into their cleanroom apparel, and even using proper gowning techniques. Watch the live feed from the University of Alberta’s NanoFab by clicking here.

Valutek is Hiring!

Think you got what it takes to be a part of the Valutek team? Right now, Valutek is hiring for a Quality Assurance Manager.

Overview 

The Quality Assurance Manager is responsible for oversight and management of Valutek’s contract manufacturing partners in Asia. The Quality Assurance Manager’s primary tasks are: (1) managing relationships with current contract manufacturing partners to insure that product quality and delivery timelines meet Valutek specifications, (2) identifying and selecting new contract manufacturing partners to establish primary, secondary and alternative manufacturers for all core products, (3) managing contract manufacturers partner’s pricing to meet established profit margins goals, and (4) providing technical expertise, information and product knowledge to Valutek team and its customers. The position oversees two Quality Auditors who work directly with the contractor manufacturers in implementing Valutek’s quality assurance programs. The Quality Assurance Manager reports to the VP of Finance/Operations in the US. The Quality Assurance Manager will work closely with the VP of Finance/Operations overseeing Valutek’s two consolidation centers in Asia.

Develop and Implement Quality Control Systems

• Implementing and maintaining quality systems and programs to ensure compliance with company and customer defined quality standards
• Establishing processes to ensure that all products shipped from contract manufacturers meet Valutek Product Specifications prior to shipment
• Reviewing and maintaining Product Specification sheets to ensure that they are accurate, up-to-date and meet or exceed current product standards
• Break product costing into component costing (i.e. raw materials, labor, packaging, energy, etc.)
• Tracking and reporting any QC Issues and corrective actions

 Identify, Select and Manage Contractor Manufacturing Partners

• Identifying, selecting and managing contract manufactures throughout Asia
• Ensuring that vendors meet or exceed Valutek standards with respect to quality, price and delivery.
• Negotiating contracts with contract manufacturers
• Establishing Primary, Secondary and Alternative vendors for all key products
• Develop and implement a system to evaluate vendor performance in meeting company goals to include Quarterly Business Reviews that you will conduct.

Manage Product Delivery and Cost of Goods

• Establishing and managing consolidated shipments from Asian contract manufacturers
• Review and maintain vendor pricing levels and meet company gross margin goals
• Consistently looking for ways to lower product costs with existing vendors or by recruiting new vendors
• Working with contract manufacturers to ensure timely production and delivery of products
• Developing systems and reports to track performance of supply chain against established standards.

Disseminate Technical Expertise and Knowledge

• Providing product training to the Valutek team
• Moderating the Cleanroom Forum website
• Writing monthly technical articles for the Cleanroom WIKI, GSFCC.org
• Contributing articles and technical insights to Valutek blog and other social media channels

 Minimum Requirements:

• 7 years experience in quality management with a least 4 in a leadership position
• Bachelor’s Degree required preferably in Quality Control, Supply Chain Management or related field.
• Knowledge and experience using ERP/MRP programs required, NetSuite experience is a plus.
• Fluent in reading, comprehending and writing both English and Mandarin.
• 3 years working with Asian-based contract manufacturers  

 Qualifications / Additional Skills / Aptitude:

• Ability to develop, train and mentor direct reports
• Drive and ambition to solve problems effectively, creatively and in a timely manner
• Ability to work well under pressure and meet customer deadlines
• Strong negotiating skills when dealing with vendors
• Ability to work well with other departments and members of the management team to achieve company goals
• Excellent grammar, verbal, and written skills.
• Strong Excel skills and the ability to construct complex spreadsheets as needed to manage Valutek’s supply chain  
• High energy level, comfortable performing multifaceted projects in conjunction with day-to-day activities.
• Resourceful, well organized, highly dependable, efficient and detailed oriented.
• Ability to establish credibility and be decisive but be able to recognize and support the organization’s values and priorities.
• Be a productive and supportive team player who gets results
• Ability to work in an entrepreneurial environment with minimal supervision.

 Travel:

• Frequent travel will be required to identify, select, and manage contract manufacturing partners in Asia as well as occasional travel to the US for management meetings

Send resumes and inquiries to

Kirk Mathers
VP of Finance
kmathers@valutek.com

About Valutek

Valutek is a high-growth firm that provides cleanroom products to leading high-technology companies located primarily in the North America. Valutek is the first company to offer all critical environment supplies from one source, and the only company to offer independent testing. More at www.valutek.com.

Valutek’s Cleanroom Gloves Blow-Out Starts … NOW!

Right now, Valutek is offering dozens of gloves products, including nylon, latex, PVC and nitrile, at rock-bottom prices (some start at just $9.95 per case!).

Download the full list of discounted glove products right now

Act now and you can order a case of Latex Powder-Free Gloves for $40.95, or a case of Nitrile Powder-Free Bagged Gloves for $55.95.

But act fast, these deals are only available as supplies last. Find out more about the big cleanroom gloves sale by clicking here, or find out more about all of Valutek’s products, incluing adhesive mats, wipers, cleanroom paper and more, by visiting http://www.valutek.com/.

Learn more about all of Valutek’s cleanroom gloves products here.

More info on Valutek’s controlled environment latex gloves.

Valutek’s Latex Cleanroom Gloves provide excellent protection against contamination and chemicals such as alkalies, acids, alcohols and ketones. (For those allergic to latex, Valutek offers alternatives such as nitrile and PVC.)

Valutek’s controlled environment latex gloves offerings include 9-inch and 12-inch Powder-Free Cleanroom Gloves, either bagged or boxed, as well as a 9” Powdered Latex Glove.

Valutek’s Boxed Disposable Latex gloves are an excellent all-purpose glove for non-critical environments. They are disposable and lightweight, powder-free and chlorinated. They are ambidextrous and have textured fingertips for improved grip.

Valutek’s Bagged Disposable Latex gloves are bagged and vacuum-sealed to reduce contamination and improve cleanliness. They are processed in a controlled environment and are powder-free and lightweight.

Quality Control
Valutek controls the specifications of its critical environment gloves from inception to delivery in its distribution centers. Beginning with the acquisition of raw material, Valutek selects 100% virgin vinyl, latex and nitrile, which is converted into gloves through a series of industry-standard processes. This guarantees that all Valutek gloves exceed your quality specifications.