It is relatively easy to avoid most of these abuse problems.

• Problem #1: You change out your diaphragm less than once a year.

There is always variability in how long a diaphragm can be used in a process before being replaced. Depending on how your system is operated, how often the diaphragm is exposed to chemicals and elevated temperatures and the diaphragm material you choose, the life of your diaphragm can be as short as a single run or as long as a year (in some cases longer). Of the different ways diaphragms can be abused this is the one that initially takes the most diligence and should be periodically reviewed to take into account any potential process changes.

When you first install a diaphragm into a system, you need to be aware of how it may react with your process and you need to periodically inspect the diaphragm to ensure it is still in working condition. CIP/SIP exposure can have a significant impact on diaphragm life. For example, depending on duration of exposure and frequency of exposure, you may need to replace a silicone diaphragm as frequently as every three months. However, under the same conditions you may be able to use an EPDM diaphragm and extend your replacement frequency to every 12 months.

• Problem #2: When installing the diaphragm on an actuator, you don’t put it all the way on.

Diaphragm threaded on partially

Diaphragm threaded on correctly and completely

This is probably the simplest problem to overcome. Every diaphragm is shipped with instructions showing you how to properly install the diaphragm. As long as these instructions are followed, you can avoid this problem.

• Problem #3: You use the diaphragm at a higher temperature then it is rated for, say using a silicone diaphragm at over 135°C.

OK, we know you aren’t gonna take a blowtorch to a diaphragm, but you should always consider what temperature your diaphragm is rated for.

This is another simple problem to prevent. The temperature ranges of our materials are available here: http://support.asepco.com/activekb/questions/148/What+is+the+temperature+range+for+an+Asepco+diaphragm%3F

By using a material that meets or exceeds your temperature requirements, you can avoid a premature failure caused by overheating your diaphragm.

• Problem #4: You don’t ever service your pneumatic actuator.

Look, Ma! No hands!! Seriously, if you can float a ping pong ball, it’s time to replace the seals.

This is one of those things that is often overlooked. Because actuators are nonproduct contact components and they typically last for very long periods of time, they may not be getting serviced at appropriate intervals. While an actuator can perform for years and years without any problems, we recommend performing preventative maintenance at least every two years with heavy use and every three years with light use. This will prevent introducing air behind the diaphragm and potentially rupturing the diaphragm.

• Finally, Problem #5: You’re using your diaphragm with process fluids it can’t handle.

This can be a tricky problem to prevent. Because every process is different, your needs may vary greatly. There are many chemical resistance/chemical compatibility charts that can be found on the Internet and while they provide some guidance, they should be taken with a grain of salt. Most of these charts have been created using a piece of elastomer in a static state. This will give you good general compatibility information, but your results will vary depending on how often you use the diaphragm and what stresses it sees when it is exposed to the fluids you use in your system.

As you can see, preventing diaphragm abuse is relatively easy. If you are interested in seeing the results of the most common diaphragm abuses, then go to http://asepco.com/asepco-products/ diaphragms/ and check out our Free Report on diaphragms.

We asked industry experts, “What is the biggest challenge facing the biotech industry today?”

The answers were interesting and while you may agree that these are challenges for this industry, you may not think they are the biggest. At the end of this article is a link (if you are reading this offline there is a web address) for you to share your opinions. We’d love to hear from you!

As you are probably well aware, the industry is always facing challenges—from technical to financial and even political. So, what do industry experts think are the biggest challenges facing the biotech industry today? Here are some of their answers.

Multi-Product Facilities

“The challenge is going to be providing process optimization, debottlenecking, and getting more throughput out of an existing facility. Drug manufacturers are concerned with efficiency and sustainability. ‘Be first to market’ was the old mantra, the cost of inefficiencies could be covered in this model. The make-up of the Biotech industry has changed, away from greenfield towards fixing old sites–rebuilding and re-tasking them.” ~ David Marks, DME Alliance

With the increased competition, increased cost of materials, and the ever-looming issues of health care reform, the need to improve efficiencies has also increased. This means a facility either needs to produce more of a specific product in an existing facility or, more likely, it needs to be producing a variety of products while minimizing the amount of downtime. The chart below (see Fig. 1) shows the difference in shipments of product from biotech manufacturers between 2002 and 2007 [Note the increase in market share of the largest companies during the same time.

Fig. 1: Biotech, decline in revenue

Fig. 2: Concentration of pharmaceutical sales (includes biotech)

See Fig. 2, more information here: Danzon, et al]

While the loss in revenue is not wholly attributable to inefficiencies, one could argue that they do have a significant impact. This leads to another area that has had and will have serious consequences for the biotech industry.

Loss of Creativity

“As big firms continue to take over small firms, creativity is stifled. In addition, heavy regulation by the government handcuffs smaller companies, further reducing the industry’s ability to offer better solutions.” ~ Reinhard Hanselka, Aidi, Inc.

There is no doubt that the biotech industry has always had a lot of mergers and acquisitions (m & a) activity. This has had a significant impact, not just on sales, but also on research and development (see Fig. 3) [You can view the full report here: NME Approvals].

As you can see, the overall trend in the industry is a decrease in the number of new compounds coming to market. During this time, merger data shows that from 2000-2010 there were over 1100 mergers and acquisitions. Of these 1100 mergers, only 18% have proved to be commercially viable so far. It would be an oversimplification to attribute this to any single factor; however, it is interesting to note that along with the trend of fewer NMEs is an increase in market share for the dominant companies (see Fig. 2).

Industry Standard

The biotech industry is still very young and the standard we use is even younger. Many industrial standards and national codes in the United States, have been around for a century or more:

• 3A Standard (food and dairy), established in the 1920′s
• National Electric Code, first published in 1897
• ASME Boiler Pressure Code, first published in 1914
• API Standards (oil industry), first published in 1924

By contrast, the ASME Bioprocessing Equipment Standard (ASME BPE), which was originally developed specifically to address equipment used in the biopharmaceutical industry, was first published in 1997. [You can learn more about the BPE here: http://www.asme.org and you can learn about the BPE Standard here: http://www.asme.org/products/codes---standards/bioprocessingequipment-% 282%29]. The process to certify vendors to verify that they comply with the BPE Standard is beginning. This presents challenges from implementation to cost.

Fig 3: Downward trend in NME applications

“We’re just beginning the BPE certification process. This is where we start backing up requirements that are contained in the Standard. Manufacturers that comply with the Standard and receive certification are put on the approved manufacturers short list, which will be posted on the ASME website. This allows an end user, like Pfizer or Genentech, or their engineering representative to easily source equipment suppliers that meet the certification requirements. Rather than expensing the cost of certifying manufacturers on their own, all they will have to do is go to the website and view a short list of certified manufacturers. This relieves them of the cost and time of doing it themselves.” ~ William M. (Bill) Huitt, W.M. Huitt, Co.

The cost is probably the most controversial aspect of certification. And while this cost can be steep, there are two places this can lead to savings. The first is when an end user or A & E is specifying equipment, instead of going back and forth with multiple vendors to verify they meet the requirements, they will simply be able to choose what are essentially pre-approved vendors, from a list of those that comply. The more significant savings potentially comes from moving the cost of compliance to the manufacturer and away from the end user. Under the current model, each end user is responsible for verifying that each individual component manufacturer meets the requirements of the Standard. Fast-forward to a time when vendors are certified to the Standard and you’ve spread the cost from the individual end user to the end users as a group.

Of course, this will add to the cost of equipment and that’s the catch. Will end users be willing to pay more for equipment that comes from a certified vendor or will they want to take responsibility and incur the cost for individually verifying that a vendor’s equipment meets their requirements?

As you can see, the opinions on the challenges the industry faces can vary greatly. Again, I invite you to comment and make sure you get in your own two cents. In the next issue: If you could change one thing about the biotech industry, what would it be?

“There is no sin except stupidity.” Oscar Wilde Lurking in every system are potential dangers, – in this case the Six Deadly Sampling Sins (speaking of Sins – you must enter this month’s wine drawing we’re giving away a total of 27 free bottles of an amazing Zinfandel*). Anyway, what are the Six Deadly Sins? 1. Seal failures cause by dynamic O-rings that become nicked in use – and then leak. 2. Specialized ports that may not properly fit the sample valves that require these O-rings – again leakage is a problem. 3. Product burn-on (“goop” formation) during SIP following sampling.  This is caused by channels that are too narrow in the sample valve to be properly cleaned between samples. 4. Product loss due to flushing “dead legs” (or “goop”) out of the sample line – using the product as flushing agent. 5. Non-representative sampling happens when the back side of the valve is not clean at the time of the sample. Typically, the sample valve carries denatured traces of the last sample. This falls into the next sample. 6. In some cases, “dead legs” or areas of non-mixing with the tank’s contents.

Any of these sins could lead to a contaminated sample.

You can imagine the costs you’ll encounter if you can’t take consistent samples – from lost product to lost manufacturing time.So, what can you do to avoid these deadly sins?One way is to choose equipment that avoids these typical problems. For example, the Asepco Sample Valve gives you: A diaphragm seal instead of o-rings – preventing leaks. Standard 0.5″ ports with no additional seals – avoiding another potential source of leaks and preventing ‘goop’ formation. A fully drainable design – no flushing required. “Behind-the-seat flowpath” – allowing CIP/SIP on the back side of the valve between samples. No dead legs – allowing all the material in the tank to be uniformly mixed. By using this sampling valve, which has been repeatedly validated in the field, you can take consistent samples throughout your process run that will be contamination free.This will effectively reduce your costs and may also reduce your sampling times.To learn more check out these links: Asepco’s sample valve “Bomb-proof” tank sampling Sample valve Animation   Next Wine Drawing Ready for a mid-winter break? Click here for our April Fools Day wine drawing. ASEPCO – Thinking Ahead – Saving You Time, Saving You Money and Improving Your Products. *Improve your odds, refer a friend.  For every person you refer we’ll give you an additional entry into our wine drawing   Give Us a Chance to Save You Money

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	More Info Find out more about Radial Diaphragm Valves

Phone: 800.882.3886

Email: sales@asepco.com ]]> http://asepco.com/2012/02/six-deadly-sampling-sins/feed/ 0 http://asepco.com/2012/02/combination-ingold-valve-assembly/ http://asepco.com/2012/02/combination-ingold-valve-assembly/#comments Fri, 10 Feb 2012 20:52:40 +0000 paul.trunzo http://asepco.com/?p=2672

The basic, but finicky, weir valve seal is the bane of many engineers’ existence. While a simple technology, it’s tricky to install, prone to leaks, and often the culprit in product contamination.

The solution: the ASEPCO Radial-Diaphragm Seal. With Tom’s passing I was reminiscing about the development of the ASEPCO Radial-Diaphragm Seal back in the early 80′s. This seal was ASEPCO’s first breakthrough product to show you how we think about your challenges. We were sure that there was a need for a better tank bottom valve.

To check our hunch, we decided to focus on the outer weir seal, which is made when placing a flattened diaphragm between the valve body edge and the actuator edge.

So, we talked to end users like you. We showed a simple diagram of weir seal failure to over 800 engineers, and 97% of them recognized the problem immediately.

We listened to their stories and confirmed their challenges:

• The weir valve requires that each bolt be tightened in a specific pattern (time consuming).
• The tightness must be the same for each bolt or you get leaks (not so easy).
• If you do it wrong, your product can leak right out onto the floor (messy).
• Even when you do it perfectly, with differential pressures and time and wear, you get leaks anyway (!!!#@$).

They were frustrated, and there were no other solutions. It was just one of those things you “have to deal with.”

So we took on the weir seal challenge. We went into the R&D labs and brought some of the brightest minds in the industry together to find a creative solution. We tried many different models (I wish I had the photos to show you—some of them are pretty funny).

Finally, late one Friday night one of our inventors got an idea while watching an old movie and after a weekend in the lab, the ASEPCO Radial-Diaphragm Seal was born.

So, what is the Radial-Diaphragm Seal and how does it work? While the weir seal is basically like sticking a gasket between two pieces of metal and screwing it down, the radial seal is more like sticking your finger in a dike. Let me explain how our Radial-Diaphragm Valve works.

First, by replacing the nuts and bolts with a simple clamp, you can easily assemble the valve body, diaphragm, and actuator. This saves you time and energy, as it closes and releases easily and quickly.

Second, the diaphragm seal moves independently of the shoulder seal (the seal between the inside and outside of the valve). Using a manual or pneumatic actuator, you can easily open and close the seal.
 
(Go here to see a video of the diaphragm in action: http://www.asepco.com/pages/videos/TankAnimation.php)

Third, the cylindrical shape of the diaphragm, when squeezed into the sealing position, holds the seal (it’s been tested to an internal water pressure of 300 psi without leakage).

Fourth, it’s rugged and easy to manage. It takes less than two minutes with a standard clamp to assemble and close an ASEPCO valve. No tools required. In fact, it’s so easy, even a caveman could do it.

Fifth, when the valve is closed, the unique CIP/SIP “behind-the-seat flow path” can be created if you add a CIP or SIP port. This flow path makes it easy to steam or clean the valve while the valve is closed. This allows for validated aseptic and sterile connections and transfers to be performed.

When we first brought the valve to market, pharmaceutical engineers were excited and a little skeptical. Most of them were still using weir-style valves for tank bottom drain valves. Over 21 years later, the majority of tank bottom valves now use a Radial-Diaphragm style design.

Continuing the evolution of valve design, we’ve taken that same radial-diaphragm technology and created a “weirless” line valve to complement our original tank valve.

You can simply drop our “inline” valve in place of any of your standard 20th century weir valves and bring your system into the 21st century.

Along the way you’ll save time and money by reducing maintenance time, improve performance with a less restrictive flow path, and simplify installation with 180 degrees of orientation.

If you haven’t been lucky enough to catch us at a show to get your hands on one of these valves, now’s your chance to see one. Email or call us today and we’ll get a demo in your hands tomorrow.

Click here for the online version of this article.

“I do not think there is any thrill that can go through the human heart like that felt by the inventor as he sees some creation of the brain unfolding to success…such emotions make a man forget food, sleep, friends, love, everything.” ~ Nikola Tesla

We admit that our customers are brilliant. Often when they have a question, challenge, or design concern they call us and we figure out a solution together. But sometimes we hear about smart ways to use our technology
after the fact.

Here are two very useful applications from the field.

How Do You Re-circulate Product in The Tank?

The Challenge: Re-circulate product in the tank while maintaining CIP/SIP and avoiding pockets or dead zones.

The Situation: A solution with small quantities of particulates that must be uniformly distributed.

The Solution: The inventive engineer used two flush diaphragm tank valves. One tank valve was used as the standard tank drain. The second valve, the re-circulating tank valve, was placed near the tank knuckle (see the diagram). To start the recycle loop, the technician opened the valve and then pumped the product through piping so it reentered at the top of the tank.

Why the Radial-Diaphragm Tank Bottom Valve?

The engineer selected our Tank Bottom Valve for two reasons:

1. Flush Mount: The flush mount of the ASEPCO Radial-Diaphragm™ Tank Bottom Valve eliminates pockets or dead zones in the tank.
2. CIP/SIP: The design of our tank valve makes SIP/CIP easy. By simply adding a secondary (Sterillite™) valve to the tank outlet valve body, SIP/CIP can be performed cleanly and quickly. In addition to making SIP/CIP easy, it doesn’t add any deadleg to your system.

How Can You Avoid Foaming and Contamination?

The Challenge: Avoid foaming that would damage a sensitive protein product and avoid the dip tube that had caused contamination in the past.

The Solution: After checking his alternatives, this engineer realized the best solution was to mount two tank valves, the standard output valve, and a smaller ASEPCO tank valve closer to the knuckle of the tank.

By setting up his 10 tanks this way, he was able to fill the tank from the bottom, eliminating foaming (see the diagram)!

Here’s the flow.

First, valve B2 (at the steam port of valve B1) is opened, allowing steam to flow through the valve and piping between the tanks sterilizing it before the product transfer.

Second, the product flows from the original tank through the piping and enters this tank through valve B1. This fills the tank from the bottom, avoiding foam and a potential source of contamination!

And finally, when the process is complete, valve B3 is opened for routine draining.

Why the Radial-Diaphragm Tank Bottom Valve?

Two reasons:

1. Avoid contamination: The steam cleaning of the valves and piping removes most of the concern for contamination. The Radial-Diaphragm Tank Bottom Valve has a flush seat that allows for thorough steam cleaning.
2. Flow control: The second tank valve allows for flow control and bottom filling. This allows the technician to effectively manage the flow and make sure there is no foaming.

Have you gone “off-label” with one of our products? We’d like to hear from you.