June 3, 2010
Saint Gobain Sealer
Have you spent time under a flow hood making difficult connections?
With the recent advent of sterile connectors in biopharmaceutical manufacturing, a great deal of emphasis has been placed on the gains in efficiency, elimination of cleaning and reduction in utilities needed in many applications. Several players (ex: Saint Gobain and Colder) have tapped into the sterile connector market as Single-Use technology continues to gain momentum. Quite simply, a sterile connection allows for the dry connection of two separate pathways, while maintaining the independent sterile integrity of both sides. Typical applications might include: the connection to a disposable bag from a bulk tank, mixing of two different types of media together or even simply entering a clean area from a non-clean environment. Sterile connections are being used in a variety of applications, spanning the full gamut of upstream and downstream processes. More often than not, the cost of a sterile connector is dwarfed by the increase in productivity associated with the product. In the past, many operators on the manufacturing floor were forced to halt production and move to a laminar flow hood to continue processing product. Biomanufacturing companies typically associate sterile connector with the use of silicone tubing.
So what’s the alternative?
Sterile tube welds are also possible to achieve the same result. Using one of several sealers in the marketplace (most notably – the C’eal Flex Sealer), the same type of connection can be made by fusing two tubes together. Essentially, the welder creates its own flow hood under plastic casing using a built-in HEPA filter. Instead of using the sterile connector coupling – the process becomes replicated by welding two tube ends together. From there, pinch clamps are released and product begins to flow again. All of this is accomplished, again, without the need to stop processes, move to a different area of the room/plant and make a connection. This type of connection is commonly associated with TPE tubing. As opposed to a silicone tube, TPE resin (such as C-Flex) allows for molding, sealing and welding.
As you can see, there is now more than one way around the utilization of a flow hood in bioprocessing. Making sterile connections on the fly allows for a number of efficiency improvements – as evidenced by the rapidly growing trend in the biopharmaceutical/biotech industry.
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Single-Use Process, Uncategorized | Tagged: C-Flex Tubing, Holland Applied Technologies, Single Use Conncecotrs, Single-Use Components, Sterile Connectors | 
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Posted by hollandapt
May 8, 2010
Holland Applied Technologies provides many different types of mixers for both food and pharmaceutical use. We
Steridose Magnetic Mixers
have listed some of the more common mixers available on the market. As always however, if you have a special application where a special type of mixer is needed please contact a Holland representative for more information.
Direct Drive Top Mount Mixers
Most well known for high speed dispersion and mixing.
- Can be mounted on the side of a tank using a C-clamp or on top with either flange or sanitary clamp fitting
- Can be used on both atmospheric and closed pressure vessels
- Shaft is driven directly by the motor and spins at the same RPM as the motor chosen
- Typical RPMs – 1750RPM – 3500RPM
- Available in Electric or Air driven models
- Most common in smaller tanks of 250 gallons or less
Gear Drive Mixers
- Most well known for stirring and keeping products in suspension
- Gears are located between the motor and the shaft causing the shaft to spin slower than a direct drive model.
- Typical RPMs 20-500RPM
- Available in Electric or Air driven models
- Wider impeller than Direct Drive models
- Require more HP than Direct Drive in most cases
Magnetically Driven Mixers
Most common in Aseptic applications where the tank is closed to atmosphere
- Mag Drive mixers have no liquid seal to maintain…the impeller is driven by a magnetic force between impeller on the inside of the tank and drive on the outside
- Bottom mounted always…..allowing for less head space above the tank
- Bottom mounted Mag Drive mixers allow for products to be mixed down to a very minimal amount of liquid in the tank. Top drive mixers cannot always mix down to the very bottom of the tank.
- Mag Drive mixers are limited in the viscosity of the product being mixed. Less viscous products are more common
Shear pump
- “Pump” located off the discharge of the tank that shears the product while traveling through
- Consists of a rotor and stator combination
- The rotor is turned by the drive and the stator is a stationary “cage that product is passed through
- Different combinations of rotors and stators produce more or less shear to the product
- Typical applications include – blending, emulsifying, texturizing, reconstitute, and dispersing
DTL Blender
- Blender for dispersing powders into liquid
- Consists of a powder hopper or powder inlet leading into a liquid blending chamber
- Continually blends powder into liquid without imparting large amounts of air
- Powder is sucked through a diffuser tube thus preventing less dust
Colloid Mill
- Consists of a conical rotor and stator combination
- Clearance between rotor and stator can be adjusted during process to achieve desired product conformity
- Used in emulsifying and texturizing
- Clearance between rotor/stator can be .001, .010 or .240”
Leave a Comment » | Uncategorized | Tagged: Holland Applied Technologies, sanitary agitators, sanitary dispersion equipment, sanitary mag mixers | Permalink
Posted by hollandapt
April 23, 2010
Masterflex Peristaltic Pump
While all silicone tubing looks very similar from a few feet away, there are inherent differences separating the field. A quick glance at market standard silicones indicates pump life ranging from 25 hours to over 150 hours under normal peristaltic pumping conditions. Clearly, there is a range and fit to certain silicone tubes on a per application basis. Beyond that, other hot topics include: extractables (organic and inorganic), validation documentation, lot traceability, manufacturing conditions and much more.
So which is right for you?
Holland Applied Technologies has been handling the Biopharmaceutical industry’s pump needs for over 50 years. Having technical expertise you can trust in will provide you with the confidence to run product smoothly and efficiently. Whether it’s a tube breaking down prematurely in your pump, extractables peaking in your HPLC or tubing particulate getting caught in your product filter – Holland has the right solution for you. Since Holland carries no less than eight different, pumpable silicone products – you will always have the ability to decide what is exactly right for your application.
Leave a Comment » | Single-Use Process, Uncategorized | Tagged: C-Flex Tubing, Holland Applied Technologies, sani-tech tubing, Sani-Tech Ultra, Single-Use Tubing | Permalink
Posted by hollandapt
March 30, 2010
There are many different types of sanitary pumps used in the pharmaceutical and food industries. Some of these types include centrifugal, Rotary Lobe, Double Diaphragm, Peristaltic and Piston type pumps.
Holland Applied Technologies sells each of the different types of pumps above for a myriad of applications. We sell many sanitary pumps into industrial applications as well because most industrial pumps are not easily cleaned after use. For instance, one customer processes different colors of paint pigment. They use a sanitary pump to allow them to clean between each color. It allows them to clean without having to remove the pump from the line and disassembling it.
Below are the main types of sanitary pumps that Holland Applied Technologies sells.
Centrifugal Pumps :
Waukesha S200 Santary Centrifugal Pump
- Good for low viscosity liquids. Run usually between 1750RPM and 3500RPM in speed. Do not require a pressure relief device.
- Flow rate up to 750GPM
- Capable of pressures up to approx 150 psi. Lower initial cost and lower maintenance costs than a positive displacement pump.
Rotary Lobe Pumps:
Waukesha Universal 2 Positive Rotary Pump
- Good for low to high viscosity products.
- Run usually between 25-500RPM in speed. Capable of approx 10 psi to 350psi discharge pressure.
- May require a pressure relief device.
- Liquid is displaced at a given amount per revolution based upon the size of the pump.
- Medium to higher initial cost and maintenance costs because of tight tolerances in the pump.
-
Double Diaphragm Pumps:
- Good for low to high viscosity products.
- Air driven (No electric motor required), positive displacement pump.
- Does not usually require a pressure relief device since it will “stall” against the incoming air pressure.
- Capable of approx 10 psi to 90 psi discharge pressure
- Consist of two large diaphragms driven by air pressure that work in unison with a ball check system to create suction and discharge pressure.
Peristaltic Pumps:
- Good for low to medium viscosity products.
- Good for lower volumes.
- Run usually at 0-600 RPM in speed. Can be air or electric driven.
- Capable of approx 2psi to 60 psi discharge pressure.
- Consists of a pump with rollers turning and squeezing against a flexible tube located internally through the pump. The pump has no wetted parts only the tubing is in contact with the product.
Piston Pumps :
- Good for low to high viscosity products.
- Good for lower volumes.
- Air driven (no electric motor required) Positive displacement pump.
- Capable of 5 psi to 300psi discharge pressure.
- May require a pressure relief valve.
- Consists of a piston that works in unison with a ball check system to create suction and discharge pressure.
Look for future HAT blogs to learn more in detail about each type of sanitary pump above.
Leave a Comment » | High Purity Product Features, Uncategorized | Tagged: Graco Pumps, Masterflex Pumps, Sanitary Pumps, Waukesha Pumps | Permalink
Posted by hollandapt
March 9, 2010
Holland Applied Technologies participates in the ASME BPE Standards Subcommittees. Many people involved in the Biotech and Pharmaceutical industries may be familiar with the ASME BPE (Bioprocessing Equipment) Standard. It is an industry Standard that contains 9 sections all aimed towards equipment and systems used in the Bioprocessing and Pharmaceutical industries. Troy Hobick from the Holland Applied Technologies Indianapolis office has been involved with the ASME BPE subcommittees for 7 years. He is Vice Chair of the Certification subcommittee and has been a part of the Design Subcommittee for 5 years. “We made a commitment at Holland to become involved and attend the meetings on a regular basis. It important for us to stay current with the BPE Standard and interact with the many industry experts at the meetings. Being one of the few pharmaceutical component distributors among the members, it allows us to stay current on industry trends such that we can inform and better help our customers” Hobick said.
The ASME BPE Standard contains the following sections :
1. General Requirements
2. Design for Sterility and Cleanability
3. Dimensions and Tolerances
4. Material Joining
5. Surface Finish
6. Seals
7. Polymer Based Materials
8. Metallic Materials of Construction
9. Certification
New topics in the ASME BPE-2009 include Hygienic Clamp and Cap dimensions, Bioreactors/Fermenters Design, Sterilizer/Autoclave Design, Elastomer performance and material property changes, Welding operator qualifications and Rouge and Stainless Steel just to name a few.
If you are interested in learning more about the ASME BPE Standard and/or where to find more information please give us a call. We can help direct you to the correct section, subcommittee or correct personnel at the ASME. Visit http://catalog.asme.org and order number A14309 for the ASME BPE-2009 copy or call 1.800.THE.ASME
Leave a Comment » | Uncategorized | Tagged: ASME BPE, Holland Applied Technologies | Permalink
Posted by hollandapt
February 18, 2010
A large pharmaceutical customer maintain the integrity of their water loop by replacing standard orifice gaskets with Holland Sanitary Orifices. The standard orifice gaskets provided by gasket manufacturers are typically molded over a flat stainless steel disc with the orifice size drilled as needed.
The problem stems from separation of the elastomer from the stainless steel orifice disc. This customer was finding rapid deterioration of the bond. During cleaning and SIP cycles the gasket material can separate from the stainless disc creating entrapment leading to microbial growth. The two dissimilar materials; the elastomer and the stainless steel disc expand and contract at different rates during temperature changes causing deformation and separation.This area of separation is virtually impossible to clean.
The Holland Sanitary Orifice is a cleaner solution to this problem. They are machined from solid stainless steel and are fully drainable in the Vertical position. They are also available in eccentric designs for horizontal installation.
Holland Sanitary Orifices
FEATURES:
- 316LSS
- FULLY DRAINABLE
- ½” THROUGH 4”
- AVIAILABLE WITH OR WITHOUT BORE PRE DRILLED.
- 25 RA STANDARD SURFACE FINISH,
- FINISHES AVAILABLE TO 10 RA
- FULLY TRACEABLE, MTR’S
Don’t compromise the sanitary integrity of your Process. Ask your Holland representative for a Sanitary Orifice to meet you piping specifications.
Leave a Comment » | High Purity Process Applications, High Purity Product Features, Uncategorized | Tagged: Holland Applied Technologies, orifice plates, sanitary orifice, WFI | Permalink
Posted by hollandapt
February 3, 2010
With the recent advent of sterile connectors in biopharmaceutical manufacturing, a great deal of emphasis has been placed on the gains in efficiency, elimination of cleaning and reduction in utilities needed in many applications. Several players (ex: Saint Gobain and Colder) have tapped into the sterile connector market as Single-Use technology continues to gain momentum. Quite simply, a sterile connection allows for the dry connection of two separate pathways, while maintaining the independent sterile integrity of both sides. Typical applications might include: the connection to a disposable bag from a bulk tank, mixing of two different types of media together or even simply entering a clean area from a non-clean environment. Sterile connections are being used in a variety of applications, spanning the full gamut of upstream and downstream processes. More often than not, the cost of a sterile connector is dwarfed by the increase in productivity associated with the product. In the past, many operators on the manufacturing floor were forced to halt production and move to a laminar flow hood to continue processing product. Biomanufacturing companies typically associate sterile connector with the use of silicone tubing.
So what’s the alternative?
Saint Gobain Connect-Flex Tubing Welder
Sterile tube welds are also possible to achieve the same result. Using one of several sealers in the marketplace (most notably – the Connect-Flex Welder), the same type of connection can be made by fusing two tubes together. Essentially, the welder creates its own flow hood under plastic casing using a built-in HEPA filter. Instead of using the sterile connector coupling – the process becomes replicated by welding two tube ends together. From there, pinch clamps are released and product begins to flow again. All of this is accomplished, again, without the need to stop processes, move to a different area of the room/plant and make a connection. This type of connection is commonly associated with TPE tubing. As opposed to a silicone tube, TPE resin (such as C-Flex) allows for molding, sealing and welding.
As you can see, there is now more than one way around the utilization of a flow hood in bioprocessing. Making sterile connections on the fly allows for a number of efficiency improvements – as evidenced by the rapidly growing trend in the biopharmaceutical/biotech industry.
Leave a Comment » | Single-Use Process, Uncategorized | Tagged: C-Flex Tubing, Connect-Flex, Holland Applied Technologies, Single Use Conncecotrs, Single-Use Tubing, Sterile Connectors, Sterile Tube Welds, TPE Tubing | Permalink
Posted by hollandapt
January 11, 2010
With the ever increasing pressure for Biotech and Pharma firms to get their products to market faster, Single Use Technology is helping allow these firms to achieve their goal. Holland Applied Technologies has increased its presence in the Single Use Technology over the past 3-5 years to help its customers achieve many goals. We have listed just some of the advantages of Single Use Technology below.
Hynetics Single-Use Mixing System
- Storage – Many End Users are requiring dedicated tanks for each their products. As a contract manufacturer, tanks need to be purchased and then stored after use. With Single Use Technology including mixing bag systems and bioreactor systems, manufacturers no longer require large storage facilities for vessels/systems that may only be used a few times per year.
- New vessels are not needed for each product – In some cases, one or multiple stainless steel vessels need to be purchased for each product a manufacturer may be formulating. Each stainless vessel will have a considerable up-front capital cost. A Contract Manufacturer can save the capital cost of buying new stainless steel vessels each time by purchasing one Single Use System. For example, a stainless steel vessel may cost $30K, while a Single Use Mixing System may cost $50K, but the stainless steel vessel can only be used for manufacturing one product, while the Single Use System can be used for numerous products and numerous end users. Huge savings can be claimed by not having to purchase multiple tanks for each end user/product.
- Cleaning/Validation costs – Single Use Technology allows any manufacturer to bypass the costs associated with Cleaning Validation
- Speeding Time to Market – Single Use Technology allows a manufacturer to decrease the time to market. Many new stainless steel vessels may take 10-20 weeks or longer to fabricate. Single Use Technology allows a manufacturer to take a bag from the shelf and be manufacturing in hours/days. No more waiting on new vessels for each new product. Simply take a new bag from the shelf and start running.
If your company is interested in a lunch/learn seminar or just a simple meeting, let us know and a Holland Applied Technologies representative can schedule an appointment.
Leave a Comment » | Single-Use Process, Uncategorized | Tagged: HyNetics, Single-Use Components, single-use mixing systems | Permalink
Posted by hollandapt
January 4, 2010
Single-Use Components Pre and Post Gamma Irradiation
The easy part of the single-use component set ups is to specify the product and define the system. The next step is to then get the single use set up validated and commissioned. One thing that always seems to be overlooked is the cleaning of the single use components/setups. As part of our service to the single use industry, we have partnered with a company that will gamma irradiate any of these parts or setups. While PTFE, FEP and other fluoropolymer based materials are not recommended for gamma irradiation, most other components can. These would include silicone tubing, C-Flex tubing, manifolds, pump tubing manifolds, single use connectors and other parts and manifolds.
Holland performs these services for several major pharmaceutical and bio-tech companies and to some companies that provide product to these industries.
Attached are some pictures that show a tubing setup that was purchased as non gamma irradiated and subsequently gamma irradiated. As a part of the service, a sticker that is placed on the bag that changes colors when exposed to the irradiation. As an added service, Holland also adds a label to the bag that states the product has been irradiated. There is also a documentation package that goes with the parts that shows the irradiation time and level of concentration.
So when you have components that need to be gamma irradiated, let us know, we have the knowhow to make you sterilization issues go away.
1 Comment | High Purity Process Applications, High Purity Product Features, Single-Use Process, Uncategorized | Tagged: Gamma Irradiated, Holland Applied Technologies, Single-Use Components, Single-Use Manifolds | Permalink
Posted by hollandapt
December 28, 2009
If you are using a low percentage bleach as a cleaning agent, their adverse effect on your stainless steel sanitary fittings and valves can be eliminated. Even a low concentration of Bleach destroys stainless steel equipment. Holland Applied Technologies has worked with our customers to provide an alternative to the stainless steel for such applications. One of our pharmaceutical customers has used stainless steel fittings and valves to disperse the cleaning agent into smaller buckets to manually clean the exterior to their processing equipment. When they were done cleaning they would also have to clean the bleach delivery tank and all associated fitting to minimize the damage due to the bleach reacting to the stainless steel. They were actually cleaning their cleaning equipment. In trying to minimize the loss in damage to the fittings and valves, we came up with a alternative cleaning procedure.
Now the bleach tank and all the smaller buckets are changed to Polypropylene. All the troublesome piping has been replaced with a single molded silicone tubing assembly. The flow is controlled with a “non-product contact” stainless steel pinch style valve. This one time conversion from stainless steel to polypropylene has not only made the process of cleaning simple and safer, it has also eliminated the need to spend valuable personnel time to clean all the associated piping. The silicone tubing assembly is used for approximately 8-10 cleanings and it is just thrown away and replaced with a new one. The tubing assemblies are purchased in quantities of 100 pieces for approximately $25.00. This was not only a safer and cleaner alternative but also a substantial cost savings to just replace the tubing and eliminate the need for personnel to have to clean fittings and valves after every use.
Please let us know if we can assist with not only your process, but also your cleaning needs.
Leave a Comment » | High Purity Process Applications, Single-Use Process | Tagged: silicone manifolds, Silicone Tubing, Single-Use Tubing | Permalink
Posted by hollandapt
