• Enter your email address to follow this blog and receive notifications of new posts by email.

    Join 408 other followers

  • Cleanroom Wipers

  • Cleanroom Gloves

    Cleanroom Gloves
  • Cleanroom Adhesive Mats

    Cleanroom Adhesive Mats
  • Cleanroom Apparel

    Cleanroom Apparel

What you don’t know about flammable liquid use in your cleanroom…

  1. Procurement, storage and document control of flammable solvents is not a walk in the park. Chemical purchasing, storage, blending, dispensing, usage, and disposal require internal resources. Updated MSDS documentation must be keep on-site.

ISO-Alc

2. Bulk chemical blending and batch filling of squeeze bottles requires protective gear, a dedicated chemical handling fume hood, and a hazardous material plan. Liquid solvents represent a higher flammability risk “3”, versus a lower flammability risk “2” for the same solvent that is pre-saturated into a wiper substrate.

80096p

3. Operator exposure to an outgassing solvent in an air turbulent controlled environment is not an OSHA winning strategy. At normal room temperatures, liquid solvents give off enough vapors to form burnable mixtures with air, which represents an environmental safety risk. Outgassing volatile organic solvents represent an operator toxic inhalation risk.

Cleanroom-Cleaning copy

4. Disposal requirements of a flammable liquid. Good manufacturing practices recommends complete traceability of flammable solvents from cradle to grave.

insp with drums


Reduce your operator volatile organic liquid solvent exposure while improving your wiper efficacy with the Valutek Pre-Wetted Wipers solution.

How?  Valutek eliminates these non-value added activities that pose environmental liability and employee exposure risk to your organization.

  • Safety:  Eliminate the need for in-plant mixing, solvent handling & transport, and open solvent containers throughout your critical environment.
  • Environmental awareness: by eliminating solvent cans and excessive solvent use, Pre-Saturated wipes reduce needless evaporation, and overuse of volatile organic compounds
  • Efficacy: Wipers are wetted to exactly 38% of the total wiper sorbent capacity  to ensure ideal mix of dwell time, and cleaning capability. An “over-saturated” wiper cross-contaminates particles. Independent studies confirm that operators “over-saturate” their dry wiper.

  • Cost Reduction: Pre-Wetted wipers eliminate all the direct and indirect costs associated with solvent handling.
  • Vacuum sealed: All chemistry is driven into wiper substrate, ensuring uniform saturation from the wiper edge to center, and from the first to the last dispensed pre-wetted wiper.
  • Innovative 3 layer film:  Transparent packaging with a lower vapor barrier transmission rate versus traditional metallic film.
  • Custom cleaning Solution:  Choose the wiper substrate (non-woven & polyester), edge treatment (knife, laser, & ultrasonic), the chemistry and concentration you need.  Valutek will manufacturer to you specification with no minimum order, to ensure maximum shelf life.

Valutek Pre-Wetted Wipers Engineered Solution

VTPNWUSI709P-99

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.

Read more

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

Cleanroom Glove Packaging. Not all gloves are packed equal

Is your glove packaged in a dispenser box? Is it labeled ‘examination glove’ ?

If so, it is not suitable for a critical environment. Why? Boxed exam gloves are designed to protect the operator. Cleanroom Gloves are engineered to both protect the operator and your critical product.

cleanroom glove packaging

 

Controlled environment gloves are flat packaged in a critical environment with the cuffs all to one end in two stacks of 50 each, double poly-bagged 100 per pack, 10 packs per case in a carton liner to ensure product integrity. Boxed gloves are not.

Over 98% of thin-wall, powder-free gloves are used in medical / lab / industrial applications. Operators of controlled environments often unknowingly procure a glove not designed to their application. Powder-free lab / industrial / medical grade boxed gloves are not suitable for a controlled environment because:

  • Boxed gloves are powder-free, not particulate-free. Uncoated chipboard dispenser boxes shed particles, and contaminate the powder-free gloves.
  • Dispenser boxes force operators to contaminate glove when donning. Operators’ bare hand should only make cuff contact.
  • Additives and fillers are often used in boxed gloves which reduce ESD compatibility (surface resistivity), and negatively impact glove cleanliness.
  • No post-processing to reduce surface contamination left from the dipping process

Engineered to protect your Product, Process & Operator

Valutek’s gloves are packed in double poly bags, vacuum sealed, flat packed in carton boxes and with a carton liner. All gloves are critical environment compatible, lot traceable with retention samples held in quality control for 36 months from date of manufacturing.

Vacuum seal benefit: better storage, no particulate release, no ESD issue

cleanroom glove packaging

 

The Cleanroom’s Dirty Little Secret

Most of the time, the “protection” part of hand protection is straightforward. Gloves are designed specifically to protect the wearer’s hands from some type of injury — cuts, spills, burns, or even repetitive use injuries that only manifest over time. The challenge is as straightforward as finding the right glove for the job — balancing comfort, performance, and protection.

In cleanroom environments, however, it isn’t so simple. These are delicate ecosystems dedicated to research and manufacturing that are sensitive to even minute impurities, and 80 percent of those impurities originate from people.1 Gloves and other personal protective equipment must limit the introduction of any particulates into the cleanroom, which means these special-use gloves are designed to protect the products as much as the wearer. Consider the potential cost of a contaminated pharmaceutical product; millions of dollars could be conservative.

CleanOperations VALUTEKWith that in mind, let’s take a closer look at hand protection for cleanrooms from both perspectives — providing protection for the wearer and for the product — and how glove technologies and design practices are addressing both needs.

Click here to read full article 

IBM: What Makes This Tiny Chip a Breakthrough

IBM showed off a prototype chip today that is being hailed as a technological breakthrough for the tiny transistors — electrical switches that help power a computer — that have been made so thin they’re 1/10,000th the width of a human hair.

The breakthrough — the result of research at IBM and the State University of New York Polytechnic Institute in Albany — could allow as many as 20 billion transistors to be placed on a chip the size of a fingernail and is half the size of the current 14 nanometer standard, company officials said. A nanometer is one-billionth of a meter.

While the technology is a prototype chip, it could have a tremendous impact “on the anticipated demands of future cloud computing and Big Data systems, cognitive computing, mobile products and other emerging technologies,” according to the company.

Moore’s Law: What’s in Store For the Next 50 Years of Computing Power

The breakthrough chip is the result of a $3 billion investment IBM made last year in partnership with the state of New York, Samsung and other technology suppliers for the purpose of chip research and design, officials said.

Click Here to Read the Full Article.

 

operators-at-suny

How to Save the Troubled Graphene Transistor

Unlike conventional semiconductors, graphene cannot be switched off, a problem that threatens to scupper its use in future generations of transistors. Now physicists think they’ve found a solution.

The writing is on the wall for the silicon chip. Transistors have been shrinking for the last half a century but they cannot get smaller forever. Most industry pundits think that the downscaling of silicon chip technology cannot extend much beyond 2026. The big question, of course, is what will replace it.

One possibility is graphene, which various teams around the world have used to make hugely fast transistors. Last year, one team clocked a graphene transistor at a cool 427 GHz. So you could be forgiven for thinking that graphene is the perfect silicon replacement.

Not so fast. There is a significant problem with graphene that makes it difficult to use in transistors– it has no band gap.

That means there is no energy range in graphene in which electron states cannot exist. Or in other words, it’s impossible to switch off graphene. And for a transistor, that spells serious trouble…

Click Here to Read the Full Article.

%d bloggers like this: