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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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Choosing the Right Pre-Wetted Wiper option for your critical environment task

Pre- Wetted Wiper Pail

The Valutek resealable pail guarantees that your last pre-wetted wipe will be as consistently saturated as the first. Our refillable pail containers are environmentally friendly, minimizing solvent evaporation, and reducing operator solvent exposure

pre-wetted-wiper-bags-and-pail

Recommended for: High Volume applications, usage of 25+ wipers per shift

  • Starter Kit: Pail + 150 wipers (2 bags) Refill: 75 wipes (1 bag)
  • Durable Hinged Top. Positive Closure: Product remains wet – Reduced out gassing
  • Sturdy Recyclable and Refillable Pail: Minimize cost by refilling the pail. Durable containers are made of 100% recyclable plastic. Simply refill the pail with convenient refill bags
  • Stock high volume of Pre-Wetted Wipers: Storage up to 150 wipes in the pail, ensuring you have adequate wipers for large scale tasks

Refill Bags 

  • Vacuum Packed: All chemistry is driven into wiper substrate, ensuring uniform saturation.Eliminates excess liquid in packaging
  • Transparent Packaging: Inspect to ensure product is particle-free

Pre-Wetted Wiper Resealable Bag

Valutek’s transparent, vacuum packaged, zip lock resealable packaging is the first break thru in pre-wetted wipers since their introduction.

Recommended for: Low Volume applications, usage of 10-25 wipers per shift

How can this innovation improve your cleaning efficacy?

  • Pre-Wetted-Pouch3 Film layers: 3 is better than 2! Laminated film has 2 layers. The Valutek film is a new film from 3 layers. The required third layer replaces foil laminates high barrier applications.
  • Zip lock closure: Positive seal versus adhesive label, once package is opened, wipers will stay pre-wetted longer
  • Transparent Packaging:  Monitor quantity remaining and inspect to ensure product is particle-free
  • Vacuum packed: All chemistry is driven into wiper substrate, ensuring uniform saturation.
    Eliminates excess liquid in pack- aging
  • Flat bag: Allows easy storage

pre wetted wiper valutek

Scientists use a Mars-like environment created in Maryland to test key rover equipment

Like its twin that’s busy exploring Mars aboard the rover Curiosity, the device known as SAM II spends its days as if it were 200 million miles away, in a very different environment than our own.  Temperatures around the instrument plunge to minus 130ºF (-90°C), the air pressure is one percent of Earth’s, and the atmosphere it sits in consists largely of carbon dioxide.  But this second SAM—short for Sample Analysis on Mars—resides in suburban Maryland, inside a tightly controlled chamber where it plays a little-known but essential role as a test instrument for the Curiosity mission to Mars.

 

Latex Glove Pricing: What can we expect in 2011?

We’ve all watched the price of latex climb and climb … and climb since 2008. But, it’s a whole new year, so what can we expect in 2011? And why?

To answer those questions, we looked to a great resource out there, The Global Society for Contamination Control. In the site’s Industry Trends section, they have an article that outlines what’s happening out there when it comes to latex raw material pricing.

With a continuously unsteady latex market causing prices to increase, Valutek clients should be aware of the outcome – increased cost of latex gloves – and their options in glove purchasing, such as nitrile and PVC.

First, a little on nitrile gloves:

Compared to Latex, nitrile is lower in particles, ionic extractable and non-volatile residues (NVR). Nitrile also has “memory” properties that adapt it to the hand for a more custom fit, reducing fatigue. It is three times more puncture resistant than latex, and also provides protection against cutting and scraping. Static-dissipative properties make nitrile ideal for all electronic industries.

Now, on PVC gloves:

Known for its inherent cleanliness (low in both particles and ionic extractables), protection against solvents, ESD properties, and low cost. These attributes make vinyl gloves ideal for use in medical device manufacturing, microelectonics and other similar controlled environments. A PVC glove fist looser on an operator’s hand than latex or nitrile, which cane reduce dexterity.

The company firmly believes that an informed customer will be able to make the best purchasing decisions for his or her critical environment. If you have any questions about latex gloves and alternative glove options such as nitrile or vinyl, don’t hesitate to contact Valutek.

To read about all your glove options, be sure to check out our Gloves Product Page.

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