At Holland, we’ve been serving the high purity process industries for over 100 years. Over that time, we have become an integral supplier to the companies that make the food you buy at the supermarket, the drugs and personal care products you use to keep yourself healthy, and the diagnostic tools healthcare professionals use to stem the tide of a global pandemic.
Recently, the work we’re doing right now to help stop the spread COVID-19 was featured on ABC7 Eyewitness News. Watch the whole story below or read more here!
Understanding the Food Safety Modernization Act (FSMA)
In today’s post, we look at just what laws and regulations are keeping the foods on our tables clean and safe. The FDA Food Safety Modernization Act (FSMA), signed into law on January 4, 2011, represents the most comprehensive and sweeping top-to-bottom reform of the United States food safety regulatory framework in over 70 years. The FSMA shifts the focus of the FDA from responding to food contamination events to prevention-based controls for manufacturing. It affects almost every business that must register with the FDA.
The FDA finalized seven major rules to implement the FSMA. The rules translate the act into specific actions at each point in the global supply chain to reduce contamination and make it easier to implement the changes. Those seven rules are:
- Preventive Controls for Human Food– Human food facilities registered with the FDA must implement a written plan that identifies hazards and outlines appropriate preventive controls.
- Preventive Controls for Animal Food– Animal food facilities registered with the FDA must implement a written plan that identifies hazards and outlines appropriate preventive controls.
- Produce Safety– Establishes minimum standards for growing, harvesting, packing, and storing produce.
- Foreign Supplier Verification Program– Importers must verify that their global suppliers comply with FDA regulations.
- Third-Party Certification– Accredits third-party certification bodies to administer voluntary consultative and regulatory audits to help companies prepare for regulatory audits or achieve certifications.
- Food Defense (intentional adulteration)– Food facilities registered with the FDA must develop a plan that assesses contamination vulnerabilities and document a mitigation strategy for each vulnerability.
- Sanitary Transportation– New requirements for companies that transport food, including shippers, receivers, loaders, and carrier.
The FDA regulates about 77 percent of the U.S. food supply. This includes everything we eat except for meat, poultry, and some egg products which are regulated by the United States Department of Agriculture (USDA). So, it is most likely that many of our food customers must comply with the FSMA. Compliance with the FSMA looks different for each business depending on the size and purpose of the facility, as well as what products it makes. Should you have any questions or want to learn more the FSMA, below are some links that provide more details on the laws and regulations for your reference:
FSMA Rules & Guidance for Industry
If you have any questions about how the FSMA impacts your process application, please contact a Holland Sales Engineer today.
S7 Weld Decay- Does your tubing and fittings pass the new ASME BPE testing requirements?
*Content for this post was sourced from an excellent article written by Carl Kettermann of United Industries. Holland is proud to offer United high purity process tubing and thank Carl for his contribution to the industry.
The 2019 edition of the ASME Bioprocessing Equipment Standard now includes a new welding requirement for stainless steel tubing. Found in Part MM – Metallic Materials of Construction, it requires that welded austenitic stainless steel tubing supplied to the industry must be capable of passing a weld-decay corrosion test and an intergranular corrosion test, as described in ASTM A249 and A270, respectively. These tests are being implemented to ensure that tubes, and the components manufactured from them, have been properly welded and heat-treated to provide optimum corrosion resistance in service. The requirement is stated as follows:
Austenitic stainless steel tube shall be capable of passing the weld decay test in ASTM A249/A249M, Supplement S7 and either the intergranular corrosion test in either ASTM A270/A270M, Supplement S1 or ISO 3651-2 Method B.
A VNE MaxPure fitting. Note that it is certified as being BPE compliant as indicated by the ASME symbol stamp.
The weld-decay corrosion test is often referred to as an S7 test and its purpose is to detect the presence of delta ferrite formed during solidification when welding austenitic stainless steel materials, such as 304, 304L, 316 and 316L. It should be noted that the BPE requirement is only applicable to the longitudinal seam welds made during the original manufacture of tubing. It is not applicable to the more highly alloyed materials like 317L and 904L or other super-austenitic materials because the nickel content in this alloy is high enough to suppress the formation of delta ferrite.
The presence of delta ferrite is a function of the chemical composition of the steel and the cooling rate of the molten weld puddle through solidification. Those welding processes that have faster solidification rates, such as laser welding, are less likely to form delta ferrite than a more traditional welding process like GTAW. This is because laser beam welds exhibit a smaller heat affected zone and smaller volumes of molten metal, and therefore typically exhibit better corrosion resistance. Delta ferrite increases the materials susceptibility to corrosive attack in reducing atmospheres, such as in hydrochloric acid, which is widely used in pharmaceutical manufacturing processes.
The ASTM A262 Practice E test referenced in ASTM A270 Supplementary Requirement S1 is often referred to as the Strauss Test and it is an intergranular corrosion test that detects sensitized structures that can form after improper heat treatment or after extended exposure to temperatures in the range of about 675 F to 1,000 F. Sensitization occurs when intermetallic precipitates such as chromium carbides are formed along the metal grain boundaries. When the chromium is bonded with carbon in these precipitates it is no longer available to form the passive chromium oxide layer that provides corrosion resistance.
Holland Applied Technologies has been one of the country’s largest suppliers of sanitary fittings and tubing to the biopharmaceutical industry for over 50 years. While there are many “bargain brands” available from all over the world, we have found that there are significant variances in quality and some producers fail to consistently meet the minimum requirements of the S7 and the Strauss test. Holland has taken significant steps to ensure that the sanitary ASME BPE fittings and tubing we provide meets the highest quality standards available. Should you have any questions on the ASME BPE Standard, or need help choosing your sanitary equipment, feel free to contact Holland Applied Technologies today.
The Affinity Laws- FAQ
At Holland, we work with applications involving sanitary centrifugal pumps every day. We’ve written before about centrifugal pumps and what advantages that they can offer. We occasionally receive questions like “How does variable speed affect my pump?” or
“Why does my motor spin at 1750 rpm and not 1800 rpm?” or “How does a 3600 rpm motor differ?”. In today’s post, we are going to try to answer some of these questions by taking a look at the Affinity Laws.
Since most centrifugal pumps are directly coupled to a standard induction motor, it follows that the pump speed is most often the motor speed. And because centrifugal pumps transfer the rotational energy from the rotor into the working fluid, it should not be a surprise that the rotational velocity and the diameter of a centrifugal pumps impeller is what determines the head, or pressure, the pump can develop.
So let us start with the motor. The speed, in RPM, of an AC induction motor depends on its number of poles and the line frequency of the power supply. This can be summ
arized by the formula:
Speed (RPM) = 2 * f (Hz) * 60-sec / Poles
Where f is frequency, in Hertz, and poles are the number of poles of the motor. Thus we see standard electric motor speeds for a 2-pole and 4-pole motor at 60 Hz to be 3,600 rpm and 1,800 rpm, respectively. So why does your 4-pole motor spin at 1,750 rpm instead of 1,800 rpm? This is due to the physics between the motor’s rotor and stator—the rotor is trying to “catch up” with the stator’s magnetic field but it will actuall
y never quite get there. This is called motor “slip” and different motors have different levels of slip.
Now what happens if we vary a motor speed on a centrifugal pump? Thanks to VFD’s, we can take the fixed 60 Hz frequency from a power supply and vary the frequency to the motor. And by varying the input frequency to the motor, we can vary the motor speed to your heart’s desire. It’s like magic! Changing the motor speed means there is a corresponding change in the pump head, flow, and power requirements of the pump. The Affinity Laws can help determine what sort of changes one can expect. Let’s take a look at them:
- The volumetric flow (Q) is proportional to the change in motor speed (N). Algebraically, this can be written: Qnew = Qold * (Nnew / Nold)
- The pump head, or pressure, (H) is proportional to the square of the motor speed. Algebraically this is written: Hnew = Hold * (Nnew / Nold)2
- The power requirement (P) is proportional to the cube of the motor speed. Algebraically: Pnew = Pold * (Nnew / Nold)3
Another set of Affinity Laws deals with changes to the diameter of the impeller. This set of laws can help to predict flow, head, and power for geometrically scaling the pump. They are written as follows:
- The volumetric flow (Q) is proportional to the cube of the impeller diameter (D). Algebraically, this can be written: Qnew = Qold * (Dnew / Dold)3
- The pump head, or pressure, (H) is proportional to the square of the impeller diameter. Algebraically this is written: Hnew = Hold * (Nnew / Nold)2
- The power requirement (P) is proportional to the fifth power of the impeller diameter. Algebraically: Pnew = Pold * (Nnew / Nold)5
As you can see, centrifugal pump performance is greatly affected by a simple change in motor speed and/or impeller size. Production managers and equipment operators like to use VFD’s to increase production. However it’s important to keep in mind that increasing production means a greater head pressure and a greater demand in power. Whether you’re looking for a change in production or you simply need to size a new pump, contact a Holland Sales Engineer today.
Commercial Update- Holland Applied Named Sole Quattroflow Distributor for Greater Midwest
Holland Applied Technologies is very excited to announce that we are now the sole authorized distributor for PSG Dover’s Quattroflow product line in North Dakota, South Dakota, Minnesota, Iowa, Wisconsin, Illinois, Missouri, Michigan, Ohio, Indiana, and Kentucky.
The Quattroflow Family of Pumps
As most of you may know, the Quattroflow pump is a positive displacement pump designed specifically for the bioprocess industry. It is a gentle, low pulsation pump that uses a series of four diaphragms and check valves to push and pull media through the pump chamber. Available in both stainless steel and single use pump chambers, the high-turndown Quattroflow pump is perfect for very many areas of biologic manufacturing such as cross-flow filtration systems, chromatography, and centrifuges. Quattroflow ensures safety, efficiency and reliability for handling biologics such as plasma products, therapeutic proteins, monoclonal antibodies, vaccines, and other high value products.
As the leading brand of quaternary diaphragm pumps, the Quattroflow series of pumps has been one of our offerings that continues to innovate by offering our biopharmaceutical customers scalability, flexibility, and performance that traditional product offerings can’t match. To learn more about Quattroflow, feel free to view our Quattroflow product page here.
We are located within your new territory. Who do I contact for Quattroflow products?
You can submit a web form through our new contact portal, or you can give us a call at if you’d like to speak to a sales engineer about your pump application today. You can also check with your existing Quattroflow supplier- they will help you get in touch with us.
Holland Applied Technologies has years of experience with service and support of Quattroflow products. If you have a technical question about Quattroflow or are trying to tackle a difficult design challenge that may involve some of our other product offerings, contact a Holland Sales Engineer today!
Our business is located outside of your territory, can I still purchase Quattroflow products from Holland Applied Technologies?
Holland is not authorized to provide off-the-shelf Quattroflow pumps and products to existing and prospective customers outside of the listed territories without PSG approval. Technical support, however, is still free. We are always happy to help you with any of your high purity fluid process challenges and can help you get in touch with the appropriate Quattroflow rep.
Whether your application requires a special motor, a pump cart or a high purity skid/module, Holland Applied Technologies will continue to utilize the best technology for your application as we have for over 50 years. If you have any additional questions about your next Quattroflow product application, please contact a Holland Sales Engineer today.
New Product Announcement- Introducing the ITT BioviZion Diaphragm Valve
On behalf of , Holland Applied Technologies is pleased to announce the launch of the BioviZion diaphragm valve. As an expansion of the EnviZion valve platform, the BioviZion valve includes fractional valve sizes (0.25”, 0.375”, 0.5”) designed for low flow applications in the Biopharmaceutical market.
The EnviZion hygienic valve platform was introduced to the market for 5 years. Awarded as the Breakthrough Product of the Year in 2014 by Processing Magazine, the EnviZion valve builds upon ITT’s reputation for innovation, quality and performance by dramatically reducing maintenance time and total cost of ownership. Let us first review the EnviZion valve platform and what makes this technology unique.
The BioviZion Valve with Manual Bonnet (left) and Actuated Bonnet (right)
With a tool-less topworks, the EnviZion valve utilizes a breakthrough mount and turn design that allows for quick and easy valve disassembly. Fasteners are eliminated and no tools are required for valve installation and diaphragm replacement—the maintenance process is simply much easier. This design allows for diaphragm changes to be reduced from an industry average of 23 minutes to 3 minutes. Just think of all of your valves in those especially hard-to-reach places—no more tools, nuts, or screws to worry about.
Another important feature of the EnviZion valve platform is that it eliminates the effects of thermal cycling with an integrated thermal compensation system. With a design that ensures a 360 degree active seal at all times, the valve does not need to be torqued following an SIP cycle(!). The EnviZion hygienic diaphragm valve passed the testing required by ASME BPE 2014 Edition Appendix J – Standard Process Test Conditions (SPTC) For Seal Performance Evaluation. The EnviZion valve received the maximum cycle rating, classified as a Level 500 seal corresponding to the number of SIP exposure/cool-down cycles, from ASME after it completed the test at three times the required test pressure.
The BioviZion incorporates all of the performance and reliability features of the EnviZion valve into a much smaller design. BioviZion, with it’s high strength stainless steel studs, eliminates traditional small fasteners. These small fasteners, standard on traditional small body valves and prone to galling, can’t provide the force required to achieve consistent and reliable sealing, especially after thermal cycling. With the BioviZion, all of these features- fastener free top works, reliable sealing, quick diaphragm changes and the patented thermal compensation system- are squeezed into a smaller package, perfect for tight transfer panel jumpers or zero static valve sampling.
Whether your application uses transfer panels, portable vessels, or a sampling system, the BioviZion is the perfect diaphragm valve to consider due to its size and ease of diaphragm change out. For more information about the EnviZion valve platform including the new BioviZion valve, contact a Holland Sales Engineer today.
HAT Partners with Princeton University for Development of Groundbreaking Flash Nanoprecipitation Mixer
Today, Holland Applied Technologies is excited to announce a new product developed with Princeton University- the CIJ and MIVM nanoprecipitation mixers. We wanted to highlight this development to not only shed light on an exciting new frontier of medicine, but also to provide a case study of HAT engineers working with our partners to develop and manufacture unique solutions for the high purity process industry.
The use of nanotechnology in medicine is spreading rapidly. A nanoparticle is a microscopic particle of a size below 100 nm. Nanoparticles can possess physical properties such as uniformity, conductance or special optical properties that make them desirable in materials science and biology. Their large surface area to volume ratio, their desirable quantum properties, and their ability to absorb and carry compounds are unique features that make nanoparticles attractive for medical purposes. Examples include products for drug delivery, gene therapy, biosensors, and tissue engineering.
In drug delivery applications, nanoparticles are utilized as delivery agents by encapsulating drugs to enhance delivery. The surfaces of the nanoparticles can be decorated with targeting agents that localize the nanoparticles at specific sites in the body. One such highly publicized application is the use of nanoparticles to deliver drugs to cancer cells. Particles are engineered to specifically interact with cancer cells, allowing for more precise treatment. This technique reduces damage to healthy cells in the body. Today, researchers continue to explore applications of the technology to other areas such as treating heart disease, glaucoma through nanodiamond (carbon nanoparticles) -embedded contact lenses, and diabetes through a mixture containing nanoparticles with a solid core of insulin.
Nanoprecipitation is a common fabrication technique used for encapsulation of both hydrophilic (i.e. having a tendency to mix with, dissolve in, or be wetted by water) and hydrophobic (i.e. tending to repel or fail to mix with water) drugs in nanoparticles. Flash NanoPrecipitation (FNP) provides a simple, rapid and scalable technique to form these drug nanoparticles.
The Confined Impinging Jet (CIJ) is the simplest mixer design for FNP and permits mixing of two streams in a scalable and continuous fashion. A Multi Inlet Vortex Mixer (MIVM) was also developed to enable up to four different stream inputs while still achieving the rapid micromixing required for uniform particle formation. The Confined Impinging Jet (CIJ) and Multi Inlet Vortex Mixer (MIVM) mixers have been designed and characterized in research led by Prof. Robert Prud’homme at Princeton University. His research group has produced a number of articles highlighting their use in the production of nanoparticles using scalable processing techniques. Holland Applied Technologies has collaborated with Princeton University in the fabrication of the CIJ and MIVM mixers. As seen below, there exists two versions of the MIVM mixer; the Micro-MIVM for 100 ml/min mixing and the MIVM for 550 ml/min mixing.
The CIJ & MIVM Flash Nanoprecipitation Mixers
FNP enables simple formulation screening that can readily be translated to commercial-scale production.
Holland Applied Technologies would like to thank Prof. Robert Prud’homme and his research group at Princeton University for their research and their continued support in the design and development of the CIJ and MIVM technologies. Holland Applied Technologies is proud to offer both the CIJ & MIVM mixers, as well as other sanitary stainless steel and single-use solutions, including needles, tanks, pumps, and manifolds to help our customers with their unique applications. For more information about your next custom sanitary application, contact a Holland Sales Engineer today.
What is the Difference Between EN 10204 3.1 and 3.2 Inspection Certificates?
When purchasing steel products, metal manufacturers should release the MTC (Mill Test Certificate) to the buyer. The MTC contains all specifications of steel products including weight, dimensions, chemical composition, mechanical strength, heat treatment status, test results, traceability, etc. This information is to ensure that a certain standard of quality for steel products has been met.
In Germany, inspection documents and certifications were originally specified in the DIN 50049 standard. The definitions of material testing and certificate types in DIN 50049 was eventually adopted for the European standard EN 10204, first published in 1991. Certificate types 2.1, 2.2, 2.3, 3.1A, 3.1B, 3.1C, and 3.2 were defined, closely following the definitions in the German standard.
EN 10204 was revised in 2004 and published as BS EN 10204:2004, Metallic Products—Types of Inspection Documents, with a simplified range of inspection documents (certificate types). These now only include types 2.1, 2.2, 3.1 and 3.2. Type 2.3 has been deleted, Type 3.1 replaces 3.1B, and Type 3.2 replaces 3.1A, 3.1C and 3.2. A brief overview of each of the BS EN 10204 certificate types is shown below:
|
Certificate Type |
Title |
Summary of EN 10204 Requirements |
| 2.1 | Declaration of Compliance with the Order |
Statement of compliance with the order by the manufacturer. |
| 2.1 | Test Report |
Statement of compliance with the order by the manufacturer based on non-specific inspections (tests) by the manufacturer. |
| 3.1 | Inspection Certificate |
Statement of compliance with the order by the manufacturer with results of specific inspection |
| 3.2 | Inspection Certificate |
Statement of compliance with the order with indication of results of specific inspection |
The standard is usually applied to metal produced by mills in the form of metal bars, plates, tube, etc. The standard can also be adapted to products manufacturers from such material such as valve bodies, flow meter casings, pressure gauges, etc. Of the 4 types for EN 10204, the latter two types are the most widely used in steel products.
Differences between 3.1 and 3.2
The EN 10204 Type 3.1 Inspection Certificate are actual test results from the material in the lot from which the steel products have been supplied (formally referred to as “specific testing”). A 3.1 Inspection Certificate is endorsed only by the manufacturers own representative who has to be independent from the manufacturing process, such as the Quality department or a test house manager/supervisor.
The EN 10204 Type 3.2 Inspection Certificate is similar to the 3.1, but has additionally been countersigned and verified by an independent third-party to validate the material by way of verification test. When the 3.2 certificate type is requested the manufacturing mill may prepare a 3.1 type certificate to present to the ‘outside inspector’ to use as a basis for preparing the independent 3.2 certificate.
With a wide offering of sanitary process components, Holland Applied Technologies is familiar with the requirements of a Type 3.1 inspection certificate and we understand its importance to our customers. While the 3.2 certificate is rare due to the higher cost, it provides independent assurance of a material’s properties. If you need more help understanding your 3.1 certificate, or simply need help retrieving a certification for a component you’ve purchased previously, contact a Holland Sales Engineer today.
Product Focus – StoneL: Valve Communication and Control
In today’s post we are going to look at our valve control top offerings .
StoneL is a global leader in process networking and valve communication for the process industries, offering a broad range of solutions that enable you to cut costs and improve performance by adopting field-based networking technology.
Quarter-Turn Applications
Axiom AN
StoneL’s Axiom AN series offers unmatched reliability by combining advanced, proven technologies with an efficient design and durable materials.
Axiom AN
The Axiom AN encloses all electrical components in a compact package for a space efficient design. The automated valve spacing envelope is minimized without compromising performance or maintainability.
Designed with the user in mind, the Axiom AN offers the utmost in ease and convenience with rapid enclosure entry and easy configuration. The Wireless Link capability provides compatible devices, such as your iPhone or iPad, a secure and convenient remote access from up to 50 meters. This capability allows for many special features such as controlling hard-to-reach automated valves, monitoring valve cycle count, and remotely entering and storing key automated valve system information including user tags and maintenance logs.
Axiom AN Wireless Link
Eclipse
The Eclipse features dual solid state sensors with optional communications neatly integrated into a sealed module. The function module and trigger/indicator
StoneL Eclipse
attach quickly and conveniently to standard VDI/VDE 3845 (Namur) actuator accessory mounting pads. The Eclipse is available in two enclosure options; the EN and the EG. The EN leverages nonincendive wiring with integral wire termination area making it suitable for all hazardous areas. The EG option is a general purpose enclosure with completely sealed micro-connector wiring.
Quartz
The Quartz is a versatile platform that can adapt to a wide variety of valve systems for a wide range of environments. With less than 5” clearance requirement, the Quartz boldly displays valve positon and encloses electrical components in an explosionproof compartment .The QX enclosure provides an explosionproof, water tight and corrosion-resistant enclosure approved for use in Div. 1/Zone 1 hazardous areas. The QN is nonincendive and approved for all div.2/zone 2 hazardous environments with proximity sensors using a clear cover. The QG is a general purpose version featuring a clear Lexan® cover with mechanical switches.
The StoneL Quartz series is durable, corrosion-resistant, and versatile.
Linear Applications
Prism PI
The Prism PI integrates an advanced position sensing system and integral pneumatic control for sanitary diaphragms and other linear applications. The Prism series offers the ultimate in ease of set-up, reliability and consistent performance.
StoneL Prism Topworks
The PI offers precision feedback for valve stroke lengths varying from 0.13” up to 2.6”. Options include three cover heights; the low profile version with no visual indicator and a medium or tall cover version both with a visual indicator.
To conclude, StoneL offers a wide variety of valve switch tops with a compact and efficient footprint suitable for many environments. Whether you use a ¼ turn pneumatically actuated valve or linear diaphragm valves, contact a Holland Sales Engineer today to find the right valve control top for you.
Viscosity of Common Liquids in Sanitary Pumping Applications
The following viscosity chart can help you get an idea of how “thick” your product is. It should be noted that these are only average viscosity estimates and we hope this chart proves useful to get an idea of the viscosity of your product when working with a Holland Sales Engineer when trying to find an appropriate solution to your application.
|
Fluid |
Viscosity (cP) |
| Water @ 70 F | 1 -5 |
| Milk | 3 |
| Blood | 10 |
| Ethylene Glycol | 15 |
| Vegetable oil | 40 |
| Corn Syrup | 50 – 100 |
| Maple Syrup | 150 – 200 |
| Tomato Juice | 180 |
| Molasses | 5,000 -10,000 |
| Mayonnaise | 5,000 |
| Honey | 10,000 |
| Chocolate Syrup | 25,000 |
| Ketchup | 50,000 |
| Mustard | 70,000 |
| Sour Cream | 100,000 |
| Peanut Butter | 250,000 |
*Chart should be used for reference only