Saint-Gobain Performance Plastics has developed SaniPure BDF, a breakthrough innovation in high-performance polymer materials. SaniPure BDF is completely certified to be free of materials of animal origin and is the ideal choice for handling sensitive biological fluid transfer applications. SaniPure BDF combines the features of traditional silicone tubing with superior peristaltic pump life performance and low absorption characteristics. This tubing answers the industry’s requirements for performance, characterization and animal-free origination.

Sani-Tech® Ultra represents the next generation in ultra-pure platinum-cured silicone tubing. Features like ultra-low extractables and longer pump life were engineered into Ultra by the experienced materials scientists of Saint-Gobain Life Sciences to meet the stringent requirements of the biopharmaceutical market.

Fluid integrity is vitally important in many biopharmaceutical applications. Sani-Tech® Ultra formulations are manufactured and packaged in a certified clean room from the finest grade of silicone materials. Ultra-low TOCs ensure that contamination by extractables is kept to an absolute minimum, and the formulation imparts no taste or odors. Saint-Gobain Life Sciences' silicone tubing is known for its superior pump life – and Sani-Tech Ultra is no exception.

Sani-Tech® Ultra tubing can be combined with Sani-Tech® Sani-Link® Ultra platinum-pured manifolds to create custom configurations for demanding biopharmaceutical applications.

Sani-Tech® STHT®-C and Sani-Tech® STHT®-65 are ultra-pure, biopharmaceutical grade Tubing. This platinum-cured silicone tubing withstands repeated autoclaving and resist the adherence of blood products and other sanitary fluids. In 1/16" ID and greater, STHT-C and STHT-65 come with laser marked part numbers and lot codes to provide total product traceability.

The inner surface of TYGON® 3350 silicone tubing has been designed to reduce the risk of particle entrapment and microscopic build-up during fluid transfer. In-house analysis of the inner surface of TYGON® 3350 silicone tubing compared to other silicone tubing shows that it is up to three times smoother. In addition, when compared to stainless steel tubing, TYGON® 3350 tubing exhibits a smoother surface by a factor of up to 40. A smoother fluid path also helps to facilitate complete sanitation of a fluid transfer system. Even in repeat use applications, TYGON® 3350 silicone tubing may prevent residue build-up, aiding in complete cleaning and sterilization. Additionally, the smooth inner surface of the TYGON® 3350 silicone tubing improves fluid flow characteristics by reducing surface area.

TYGON® 3350 silicone tubing is compounded to meet the most demanding requirements of biocompatibility. In-house extractability tests have shown that TYGON® 3350 silicone tubing has a low extractable content. Lower extractables help to maintain the purity of transported fluids in sensitive applications. Platinum-cured TYGON® 3350 silicone tubing complies fully with the requirements of the USP Class VI Criteria and is entirely non-toxic, non-hemolytic and non-pyrogenic. Additionally, TYGON® 3350 silicone tubing meets 3-A Sanitary Standards, FDA 21 CFR Part 177.2600 Criteria and NSF 51 Standard. TYGON® 3350 silicone tubing also complies with the ISO 10993 guidelines for contact with blood (or other body fluids and tissue) for up to 30 days as listed in the FDA GP-95.

PharMed® BPT biocompatible tubing is ideal for use in peristaltic pumps and cell cultures. PharMed® BPT tubing is less permeable to gases and vapors than silicone tubing and is ideal for protecting sensitive cell cultures, fermentation, synthesis, separation, purification, and process monitoring and control systems. PharMed® BPT tubing has been formulated to withstand the rigors of peristaltic pumping action while providing the biocompatible fluid surface required in sensitive applications. With its superior flex life characteristics, PharMed® tubing simplifies manufacturing processes by reducing production downtime due to pump tubing failure. The excellent wear properties of PharMed® BPT translate to reduced erosion of interior tubing walls, improving overall efficiency of filtering systems.

PharmaPure is a premium, low spallation, biologically compatible peristaltic pump tubing developed especially for pharmaceutical, biotechnology, and laboratory applications. This tubing meets the demanding challenges of providing unsurpassed pump life, with ultra-low particulate spallation and very low permeability. PharmaPure’s superior flex life characteristics simplifies the manufacturing process by reducing production downtime due to pump tubing failures. PharmaPure has low permeability and is ideal for protecting sensitive cell cultures, fermentation, separation, purification, process monitoring, and sterile filling.

Sani-Tech Sil-250 is a high-performance platinum-cured extended-life silicone-tubing formulation specifically designed for demanding peristaltic pump applications. With its superior flex life characteristics, manufacturing processes can be simplified by reducing potential production time due to pump tubing failure. Sani-Tech Sil-250 has an extreme smooth inner surface that helps reduce the risk of particle entrapment during sensitive fluid transfer.

Saint-Gobain's PharmaFluor® FEP fluoropolymer tubing meets the highest demands of biopharmaceutical, medical and laboratory applications. This tubing is formulated to resist the absorption/adsorption of aqueous fluids, which minimizes the risk of fluid alteration in single or repeat use applications. PharmaFluor FEP tubing has outstanding chemical and physical characteristics, and processing of PharmaFluor FEP occurs under stringently controlled conditions. In addition to being chemically inert, this tubing can be used at temperatures ranging from -100°F to 400°F (-70°C to 204°C). It is also virtually unaffected by chemical sanitizers and cleaners and can be cleaned repeatedly without decreasing its service life.

Tygon S3 E-3603 flexible tubing handles the most stringent foods and beverages. It is crystal clear, crack-resistant as well as non-oxidizing, non-contaminating, and less permeable than rubber tubing.

Tygon S3 E-3603 is specially formulated for resistance to flex-fatigue and abrasion and offers superior life, which minimizes the labor and expense of replacement. Its clear, glassy smooth inner bore helps prevent buildup to facilitate cleaning. Coils are marked at 30.4 cm intervals for easy measuring.

Saint-Gobain's bio-based Tygon S3™ flexible tubing line combines the high-performance standards customers demand with an eco-friendly, phthalate-free design.

Maintaining fluid integrity during transfer is critical in numerous pharmaceutical and biotechnology applications. Loss of fluid through migration into the tubing walls can cause inconsistencies in final product results. TYGON® 2475 High Purity Tubing is hydrophobic and will resist the absorption/adsorption of aqueous fluids. This reduction in absorption/ adsorption minimizes the risk of fluid alteration in single or repeat use applications.

Until now, clear, flexible tubing was restricted from use in many applications due to concern of plasticizer extraction. TYGON® 2475 High Purity Tubing is entirely free of any plasticizers. This unique tubing uses the latest in polymer technology to provide an entirely clear and flexible tubing choice for sensitive fluid transfer applications.

TYGON® 2475 High Purity Tubing is virtually unaffected by chemical sanitizers and cleaners. As a result, it can be cleaned repeatedly without decreasing its service life. The non-wettable surface of the product facilitates complete drainage of fluid during the cleaning process. TYGON® 2475 has a masterfile with the U.S Food and Drug Administration.

Maintaining product integrity during fluid transfer is critical in most pharmaceutical and biotechnology applications. Loss of fluid through migration into the tubing or adherence of fluid onto the tubing walls may create inconsistencies in final product results. TYGON® 2475 I.B. High-Purity Tubing is hydrophobic and resists the sorption (absorption/adsorption) of aqueous fluids. This reduction in sorption minimizes the risk of fluid alteration in single or repeat-use applications.

Until now, clear, flexible tubing was restricted from use in many applications due to concern of plasticizer extraction. TYGON® 2475 I.B. High-Purity Tubing is entirely free of any plasticizers. This unique tubing uses the latest in polymer technology to provide a clear (between braid) and flexible tubing choice for sensitive fluid transfer applications.

TYGON® 2475 I.B. tubing is virtually unaffected by chemical sanitizers and cleaners. As a result, it can be cleaned repeatedly without decreasing its service life. The non-wettable surface of the product facilitates complete drainage of fluid during the cleaning process. In addition, TYGON® 2475 I.B. tubing can be sterilized easily using conventional gamma radiation, and gas (ethylene oxide). TYGON® 2475 I.B. has a masterfile with the U.S Food and Drug Administration.

AseptiQuik® C Connectors provide quick and easy sterile connections, even in non-sterile environments. AseptiQuik's “CLICK-PULL-TWIST” design enables users to transfer media easily with less risk of operator error. The connector's robust design provides reliable performance without the need for clamps, fixtures or tube welders. Biopharmaceutical manufacturers can make sterile connections with the quality and market availability they expect from the leader in single-use connection technology.

BarbLock ultra-secure retainers are the most advanced design available in today’s demanding connective applications. When it comes to retaining flexible tubing and Hose onto barbed fittings, BarbLock retainers are the only system with a full 360° Radial crimp behind the barb and 360° of compression directly over the barb’s ridge. BarbLock® retainers have become the standard in many industries including the Biopharmaceutical, medical, and laboratory markets, because it solves inherent leak path problems from sensitive and demanding applications. The retainer uses no Adhesives or solvents and is ideal for systems transferring delicate liquids or gases. The system is quick and easy to assemble saving valuable time.

Pure-Fit SIB is a smooth inner bore (SIB) fitting and assembly system that provides a seamless transition of tubing and fittings, maintaining complete fluid integrity throughout the system. Quick and secure connections, as well as the prevention of fluid contamination and product loss through leakage, are critical in biopharmaceutical applications. Pure-Fit SIB, with its patented 360° compression seal, is the solution to these potential problems.

Pure-Fit SIB’s unique internal design reduces the risk of tubing being punctured or cut from sharp, barbed edges like those on traditional fitting systems. Because of the smooth inner bore design, Pure-Fit SIB eliminates turbulence (dead space) or stagnation of fluid flow, which creates areas for potential bacteria growth.

The Pure-Fit SIB system is ideal for making single-use manifolds and tubing sets. It offers more flexibility than molded manifolds. Pure-Fit SIB fittings systems are compatible with all of our silicone tube offerings as well as TPE tube including C-Flex. Manifolds can be assembled in-house. Holland Applied Technologies also offers manifold assembly services, including clean room assembly and gamma irradiation.

Pure-Fit SIB utilizes the patented BarbLock® retention and sealing system, providing complete 360° compression along the entire fitting system. Constructed from the highest quality polypropylene or PVDF, the components and systems are completely autoclavable and sterilizable. Pure-Fit SIB fitting systems have been engineered to provide a complete, undisturbed fluid flow path through all flexible tubing. Saint-Gobain Performance Plastics offers a broad line of flexible tubing formulations that are ideally suited for use in conjunction with your particular application and the Pure-Fit® SIB® system.

The HFC Disconnect Series enables sterile disconnection of single-use biopharma and cell and gene therapy manufacturing systems. With an easy push of the connector thumb latch, sterility is maintained on both sides of the system during the disconnection process. Ideal for disconnection from storage/mixing tanks, SU bioreactors, transfer lines, chromatography skids, filters, sampling, and freeze/thaw bags. Sold in the connected set, including a protective thumb latch cover eliminating the chance of an accidental disconnection. Laser etched with item and lot number for batch traceability.

CPC's AseptiQuik® STC Connectors integrate the AseptiQuik sterile connector and the Steam-Thru® II SIP connector, giving manufacturers flexibility between hybrid stainless steel and single-use processing equipment. The AseptiQuik STC connector combines either an AseptiQuik G, AseptiQuik S or AseptiQuik C sterile connector with a Steam-Thru II connection that can be mounted directly to stainless steel processing equipment via a sanitary termination. AseptiQuik STC connectors utilizing an AseptiQuik G or S sterile connector offer a genderless design, simplifying system integration at the aseptic connector end. AseptiQuik STC connectors utilizing an AseptiQuik C sterile connector allow system designers to incorporate a keyed female-to-male connection at the aseptic connector end.

The union of the two connectors into a single unit through a sanitary clamp allows an AseptiQuik sterile connection to be steamed on to stainless equipment via SIP. After the SIP cycle, a wide range of single-use systems can be connected. The SIP process can be done in advance allowing a quick and easy sterile connection to the AseptiQuik half without having to wait 30-60 minutes for SIP prior to harvest.

CPC's Steam-Thru Connections Steam-Thru® Connections allow a quick and easy sterile connection between biopharmaceutical processing equipment and disposable bag and tube assemblies. The single-use design saves time and money by eliminating unnecessary cleaning procedures and reducing validation burden associated with reusable components.

Single-use technologies are playing a key role in the reduction in risk of cross contamination in addition to time and cost benefits associated with assembly, cleaning and cleaning validation. Bio-Simplex™ Sterile Bottle Assembly Systems are available in a range of commonly used sizes from 60mL to 2 Liter. Each single-use sample bottle includes a 2 port EZ Top® Closure, made from C-Flex® pharmaceutical grade thermoplastic elastomer (TPE) resin and tubing, engineered to ensure an unobstructed fluid path, extremely low levels of extractables and a secure elastomeric seal between bottle and cap surfaces. Each system is equipped with a PETG bottle (2 Liter is poly-carbonate), a 0.2 ?m vent filter, an 18” length of 1/8”ID x 1/4”OD C-Flex tubing with a plug end, notched dip tube to the bottom of the bottle and a polyethylene cap (polypropylene on 2 Liter). Economically designed for the single-use market, sample bottle assemblies are easily used with sterile connecting devices and thermal tubing sealers.

Bio-Simplex™ Sterile Bottle Assembly Systems are sold as single items, each double bagged and gamma irradiated for a Sterility Assurance Level (SAL) of 10-6. Customer-generated designs, sizes, packaging and other options –– such as connectors, heat-sealed ends or alternate materials –– are available as custom orders.

The Bio-Simplex™ Carboy Closure System features an EZ Top® Closure Assembly made from C-Flex® pharmaceutical grade resin and tubing, engineered to ensure an unobstructed fluid path, extremely low levels of extractables and a secure elastomeric seal against plastic, glass and metal surfaces. The EZ Top® Assembly includes C-Flex® tubing with standard plug end fittings, a Bio-Simplex™ Flex Joint™, 0.2 ?M vent filter and cap. Economically designed for single use, the Bio-Simplex™ Carboy Closure System eliminates cleaning and contamination from repeated use. It is easily used with sterile connecting devices and thermal tubing sealers.We offer standard 2 and 3 port configurations to fit a wide variety of carboys in sizes from 5 to 20 Liters.

Available as a complete packaged Bio-Simplex™ Carboy Closure System (EZ Top® Assembly, carboy and cap), either gamma irradiated or non-irradiated; or as individually packaged EZ Top® Closure Assemblies. Custom designs, materials, sizes, packaging and other options––such as quick disconnect devices, Luer connections, heat-sealed ends or alternate carboy materials––are available on request.

Saint Gobain now offers the Bio-Simplex™ Polypropylene Carboys for advanced liquid handling and solution storage for many pharma applications. Saint-Gobain offers four popular sizes of carboys: 5 L, 10 L, 20 L and 40 L manufactured from high quality polypropylene, which is resistant to chemicals . Many times, users autoclaving plastic carboys experience deformities/collapsing from elevated temps. Not with these. The Bio-Simplex carboys can withstand sterilization temperatures up to 275°F (135°C)

The carboy’s body includes design features that allow the user to easily hold, lift, fill, and pour while the versatile Container closure technology provides interchangeable and leak-proof topconnections. The Bio-Simplex carboys are available with or without an autoclavable spigot. They also feature easy-to-read certified graduation marks with ± 5% accuracy, large molded marks for clearly identifiable volume and material. The Bio-Simplex system–carboy, cap, and spigot is autoclavable.

Additionally, a Bio-Simplex Container Closure can be added to create a complete container assembly when combined with cap and container. This economical assembly, designed for single use, can successfully replace stainless steel closures and eliminate costs such as cleaning, validation and assembly, and the contamination from repeated use.

Economically designed for the single-use market, Bio-Simplex™ Sampling Manifold Systems are available with either four, six, eight or ten 60mL sampling bottles and an additional 500mL purge bottle at the end of the manifold. Each 60mL PETG bottle is connected to the Bio-Simplex™ manifold with 10 inches of tubing with a clamp, an EZ Top® container closure, a 0.2 ?m vent filter and polyethylene cap. All EZ Top®s, tubing and manifolds are made from animal derived component free (ADCF) pharmaceutical grade C-Flex® thermoplastic elastomer (TPE) resin –– engineered to ensure an unobstructed fluid path, a secure elastomeric seal against each bottle with extremely low levels of extractables.

Bio-Simplex™ Sampling Manifolds are easily used with sterile connecting devices and thermal tubing sealers. They are sold double bagged and gamma irradiated. A carrying traydesigned for up to ten 60mL sample bottles and one 500mL purge bottle is included.

Bio-Simplex Sampling Manifolds Ideal Applications

The standard 4, 6, 8 or 10 bottle sampling manifolds provide ideal solutions for aseptic sampling, sterile additions, and for pulling samples to be retained. In the typical cell culture application, using the system provides a simple and easy mechanism for taking daily or periodic samples without breaking into the production line. This system also provides an ideal method to pull batch samples in the final formulation of your product. This sales literature provides details on our standard Sampling Manifold line. If you have a specific application that requires some modification or customization please call us and let us know your application.

Single-use technologies are playing a key role in the reduction in risk of cross contamination in addition to time and cost benefits associated with assembly, cleaning and cleaning validation. Bio-Simplex™ Spinner Flask Accessories are designed to allow user to maintain their current investment in glassware, but with the convenience of a single-use filling assembly. Molded one piece construction creates a seamless fluid path and unobstructed inner bore, eliminates contamination and product loss due to loose connections. The assembly includes:

1.) an EZ Top® stopper, made from C-FLex® pharmaceutical grade animal derived component free (ADCF) thermoplastic elastomer (TPE) resin and tubing to insure an unobstructed fluid path, extremely low levels of extractables and provide an elastomeric seal against glass, plastic and metal surfaces.

2.) a Bio-Simplex™ FlexJoint™ which uses a patent-pending design and construction to accommodate angle deviation in hand blown spinner flasks and eliminate tube kinking and shape loss after autoclaving.

3.) a polypropylene cap. Bio-Simplex™ Spinner Flask Accessories are easily used with sterile connecting devices and thermal tubing sealers.

We offer standard 2 and 3 port configurations in 1, 3, 8, 15 and 36 Liter sizes, sold as single items. All are autoclavable.

Customer-generated designs, sizes, packaging and other options –– such as connectors, heat-sealed ends or alternate materials –– are available as custom orders.

The number one choice of the biopharmaceutical industry in single-use Erlenmeyer Flask assemblies, Bio-Simplex Erlenmeyer Flask Closures are now available solo (Closure Assembly) or with a standard polycarbonate flask (System). The Bio-Simplex Erlenmeyer Flask Closure Assembly features the EZ Top® assembly,made from pharmaceutical grade C-Flex® thermoplastic elastomer (TPE) resin and tubing, and is engineered to ensure an unobstructed fluid path, extremely low levels of extractables and a secure elastomeric seal against plastic, glass and metal surfaces.

The Erlenmeyer Flask Closure Assembly includes C-Flex® tubing with a choice of either male Luer connections or CPC®quick disconnect fittings, a Bio-Simplex FlexJoint, 0.2 ?m vent filter and polypropylene cap. Economically designed for the single use market, both the Bio-Simplex™ Assembly and System eliminate cleaning and contamination from repeated use. They are easily used with sterile connecting devices and thermal tubing sealers. Standard configurations include 2 port configurations in 1, 2 and 3 Liter sizes, available as individually packaged Bio-Simplex Closure Assemblies or a complete packaged Bio-Simplex Erlenmeyer Flask System (Bio-Simplex™ Assembly, Erlenmeyer Flask and cap). Both come gamma irradiated.

Customer-generated designs, sizes, packaging and other options –– such as connectors, heat-sealed ends or alternate materials –– are available as custom orders.

Manufactured from high-purity, platinum-cured silicone elastomers, thermoplastic elastomer, or thermoplastics, our Sani-Tech® Sealing and Transfer System components provide an aseptic seal for handling various high-purity fluids in biopharmaceutical applications. The Sealing and Transfer Systems allow you to easily retrofit your existing glass and plastic carboys, glass solution and media bottles and stainless steel vessels for aseptic fluid transfer, sampling or sealing.

All Sealing and Transfer Systems materials of construction are non-cytotoxic and comply with USP Class VI standards.

Sani-Tech ultra-pure, platinum-cured silicone stoppers outperform standard neopreneand rubber stoppers in critical process and laboratory applications in terms of life expectancy, consistency, and purity. Sani-Tech silicone stoppers are fully autoclavable and sterilizable and will not crack, cause spallation, or release particulates that could cause process contamination or lost product.

Sani-Tech silicone stoppers can be supplied with cored holes for use with specially designed dip tubes or vent configurations. Custom identification markings can also be utilized to help differentiate supply lines.

Sani-Tech Silicone Stoppers Characteristics

The manufacturing process of the silicone stoppers is carefully controlled from receiving through production and inspection and lot traceability is readily accessible in all stages through batch number assignments.

Saint-Gobain Performance Plastics ISO 9001 manufacturing facilities have the ability tocreate a wide variety of customized silicone stoppers including color coding and coring options to fit the demanding applications of the pharmaceutical, biotechnology, and laboratory environments.

Biocompatability

Sani-Tech® ultra-pure silicone stoppers are manufactured from a biopharmaceutical gradeof silicone materials and are fully characterized from a biological, chemical, and physical standpoint. Sani-Tech® stoppers are tested to specifications including USP Class VI and FDA 177.2600 criteria. Sani-Tech® ultra-pure silicone stoppers have a masterfile with the U.S Food and Drug Administration.

Pure-Fit SIB is a smooth inner bore (SIB) manifolding system that provides a seamless transition of tubing and fittings, maintaining complete fluid integrity throughout the system. Quick and secure connections, as well as the prevention of fluid contamination and product loss through leakage, are critical in biopharmaceutical applications. Pure-Fit SIB, with its patented 360° compression seal, is the solution to these potential problems.

Pure-Fit SIB’s unique internal design reduces the risk of tubing being punctured or cut from sharp, barbed edges like those on traditional fitting systems. Because of the smooth inner bore design, Pure-Fit SIB eliminates turbulence (dead space) or stagnation of fluid flow, which creates areas for potential bacteria growth.

The Pure-Fit SIB system is ideal for making single-use manifolds. It offers more flexibility than molded manifolds. Pure-Fit SIB fittings systems are compatible with all of our silicone tube offerings as well as TPE tube including C-Flex. Manifolds can be assembled in-house. Holland Applied Technologies also offers manifold assembly services, including clean room assembly and gamma irradiation.

The C-Flex® molded manifold is a revolutionary follow up to Saint Gobain’s silicone equivalent, Sani-Tech® Sani-Link® manifolds. Both C-Flex® molded manifolds and Sani-Tech® Sani-Link® manifolds utilize smooth bore technology and eliminate the need for traditional fittings and cable ties. The difference is the TPE technology.

In the past, end users were required to use only silicone in their molded manifolds. Now you can pick whichever of the two materials you prefer – and have a completely molded solution. Entrapment points, leaking tubes and contamination will be significantly reduced with the implementation of this fully molded system.

Process engineers and designers can specify any combination of manifolds. C-Flex® molded manifolds are available for use with in an infinite # of configurations. All you have to do is provide a drawing and we can customize a part specific to your needs. C-Flex® molded manifolds can be autoclaved and gamma irradiated.

C-Flex® molded manifolds are manufactured from the finest grade of TPE materials and are fully characterized, validated and tested to a variety of specifications including USP Class VI criteria, ISO 10993 and European Pharmacopoeia 3.1.9.

The Sani-Tech Sani-Link manifold is a true industry first and has been awarded a U.S. Patent (No. 6,290,265) for its unique features. Utilizing S.I.B® (Smooth Inner Bore) technology Sani-Link minimizes the need for fittings, connections or assembly and all leak points and entrapment areas have been eliminated.

Sani-Tech Sani-Link are manufactured from custom biopharmaceutical-grade silicone and is completely characterized to help with your validation processes. Sani-Link can be supplied in a wide array of shapes and sizes to adapt to your specific applications.

Fluid Line Technology's line of pinch valves allow the user to control flow through hoses without product contact. The valve simply hinges and clamps over the hose. Its compact design allows the pinch valve to be placed onto systems with minimal space requirements. Available in 2-way, 3-way, and 4-way configurations.

Components are made only from certified USP Class IV materials.

There are six standard pinch valve sizes with special hose configurations available upon request. The featured color-coded bonnet options allow for process or system identification.

Fluid Line Technology's Disposable Sampling Valves come in two different styles: Single Use and Limited Use. Single Use is designed to last 3 cleaning cycles while the Limited Use is designed for up to 12 cleaning cycles*. This allows our customers to fine-tune their disposable process needs to minimize cost while maximizing throughput. Each design is made from only certified USP CLASS IV materials with a steam sterilizing capability of 121o C for 30 minutes.

Each Disposable Sampling Valve comes in a sealed pouch (ready to sanitize) or a gamma irradiated pouch (ready to use). Contact us for more information about sizes and configuration options.

*Refers to CIP or autoclave

BioPure BioClamps are a patented plastic tri-clamp with quick release, specifically designed to meet the needs of busy pharmaceutical and bioprocessing laboratories. Constructed of Nylon, these clamps can be autovclaved. With their light weight and ease of use, BioClamps offer a cost effective alternative to traditional stainless steel Tri-Clamps for single use, disposable proccess applications.

BioPure BioClamps™ are available in sizes 1/2" through 4". BioClamp sanitary single-use clamps are more compatible with current Pharmaceutical and Biotech manufacturing standards, They offer greater an excellent, low cost option to stainless steel Tri-Clamps for single-use disposable sanitary process systems.

The Pure-Fit® Tru Valve is an innovative single-use valve design that allows the operator to install the system over standard flexible tubing or a finished- assembly system. The superior lightweight construction allows the fluid floor to be accurately controlled with a calibrated scale on both sides to assist with validation protocols. The Pure-Fit® Tru Valve was not only designed to meter fluid flow, but also as an effective, secure method to close off and lock out a tubing system during a steam-in-place (SIP) cycle.

Pure-Fit Tru Valve Characteristics

The Pure-Fit® Tru Valve is completely constructed from light weight borosilicate reinforced nylon material and is also fully autoclavable and sterilizable utilizing gamma irradiation.

The Pure-Fit TC Tube Clamp System represents a new generation of clamping technology for the pharmaceutical industry. It features an outer body with no sharp edges, eliminating the potential for snags, scratches or punctures; a press-down locking system that is fully encapsulated to guard against untimely or unwanted release; and a side release mechanism that facilitates secure, single-handed installation and operation. Pure-Fit TC features an integral bore hole for absolute lock-out capabilities. The innovative design allows for complete flow stoppage and can be installed over the tube in the normal fashion or put together after the tube is already part of a completed assembly.

The all-new Vante® 4160-series TPE Tubing Sealer is the obvious choice for the reliable, efficient creation of permanent seals in thermoplastic tubing common in single-use manufacturing procedures performed in biopharmaceutical cleanroom production suites, allowing for ease of separation at the seal area. It operates with voltage rated inputs of 100-120 VAC or 230 VAC. The connection of an external compressed air supply is not required. Offering the ultimate in portability, this tubing sealer can be easily moved throughout the suite. The durable, maintenance-free sealing heads are connected to the controller with an 8ft cable and are equipped with a remote cycle-start feature to make this the only TPE Sealer offered standard with truly remote tube sealing capabilities. The controller is equipped with 2 levels of password protection for quality assurance and process control. A simple, user-friendly control panel allows for accurate configuration and operation. The sealing heads have a built-in safety lock feature to prevent them from being opened once a sealing cycle has been initiated. This all-new Vante TPE Tubing Sealer consists of the Model 4160 Controller and interchangeable sealing heads – Model 4161 Sealing Heads for thin-wall TPE tubing, and Model 4162 Sealing Heads for thick-wall TPE tubing up to 1-inch outside diameter.

The TPE Sealer produces consistent, quality seals on most TPE tubing used in biopharmaceutical manufacturing. This sealer is easy to clean, portable and compact. One-button operation makes this sealer easy to use and validate. The unique remote thin wall sealing head clamps and hangs from tubing for convenient use with manifold systems. The Thin Wall Sealing Head seals thin wall (.062) tubing: .125 OD – .375 OD. Operates 100-240V, 50/60 Hz outlet (Compressed air required) CE marked.

The Vante® Sterile Connector is an automated table top device which produces a singular aseptic tubing connection from two separate tubing segments. The Model 3960 is designed for use in biopharmaceutical manufacturing applications where aseptic tubing connections are required. It is a stand-alone automated table top device that requires minimal user interface for ease of operation. The unit incorporates self-controlled heating operation and temperature monitoring as well as an automated mechanical assembly to perform the tube welding operation. A cover protects the user during the operation. The Welder requires a single use, disposable cutting blade which is purchased separately from the unit. The tubing can be wet, dry or fluid filled.

Mitos DuraPure™ bags are available in pillow and 3D styles, from 50mL to 1000L. Made from two films, Mitos DuraPure bags offer a high-purity contact surface with a durable exterior to protect your product. The inner film is virgin low-density polyethylene (LDPE). The outer film is a multifunctional co-extrusion of linear low-density polyethylene (LLDPE), ethylene vinyl alcohol (EVOH) and ethylene vinyl acetate (EVA). The outer film provides a secondary high-purity surface (LLDPE), a permeation barrier (EVOH), and puncture and tear resistance (EVA). DuraPure bags are USP Class VI and are animal free.

Now you have the option of autoclaving your bags. Mitos klave-it® bags are made from a select Kynar™ PVDF film designed to maintain flexibility, strength and impact resistance after sterilization by autoclave. Other benefits include chemical and solvent resistance, low TOC (total organic carbon) and low permeability. Klave-it bags are USP Class VI and animal free.

Along with our broad offerings of sanitary pumps, we also design and build complete pump skids, carts and sanitary pump process systems. We will work with you to design a pump skid designed for you specific application. The process starts with reviewing your application and specifying the most efficient, cost effective pump for the application. We can assist in proper seal selection, drive selection and specifying the other process components required to meet your application.

Our custom UL-listed panels are designed and built with safety and reliability in mind. Holland Applied Technologies is a UL listed 508A (Standard for Industrial Control Equipment) and UL 698A (Standard for Industrial Control Panels Relating to Hazardous (Classified) Locations) panel fabrication shop. We are qualified to design and build UL 508A and UL698A Listed control panels to your custom specifications.

When working with high value products, any liquid left in a piping system can be costly. We offer a line of sanitary orifices the reduce this risk when a fixed orifice pressure reduction is required in the process. Unlike most orifice plates which can leave some liquid on the upstream side of the plate, the Holland sanitary orifices are fully draining when mounted in the vertical position. The tapered interior design ensures that there will be no product hold up.

When making sanitary manifolds, using the “fish mouth” fabrication method has many shortcomings;

• It requires a difficult hand weld
• It is difficult to know if full penetration of the weld area has been accomplished.
• The weld is difficult to polish
• Once polished, it is impossible to tell how much wall thickness is left in the joint

When working with high value products, quality and flexibility is paramount. Holland Applied Technologies has spent the last 10 years pioneering novel product dispense products and technologies in both Stainless Steel and Disposable materials for all major OEM filing machines.

We design and manufacture custom sanitary jacketed assemblies for both heating and cooling applications, including:

• Sanitary spool pieces and piping assemblies (including jacketed holding tubes)
• Sanitary fittings
• Pump casings
• Diaphragm valves
• Ball valves
• Sanitary single seat valves

There is a wide variety of stainless steel sanitary process connection systems used in the world. European sanitary fittings systems include DIN 11851, SMS, RJT and IDF fittings. Often, process equipment built in the Europe comes to the US with stainless steel piping using one of these connection systems. We build custom adapters to allow users to transition to sanitary clamp systems in a clean and efficient manner.

We have been designing and building sanitary flow transfer panels and sanitary utility panels for over 25 years. Our completed projects range from simple 3-ports flow diversion panels to highly complex 3 dimensional sanitary flow transfer panels with over 100 ports and electronic feedback on each circuit. Our client list consists of most of the major biopharmaceutical manufacturers in the U.S.

Sanitary stainless steel spool pieces are available in up to 20 foot lengths. Standard materials are 304 and 316L stainless steel. Sanitary spools are also available in higher alloy such as AL6XN and Hastelloy are also available.

When working with high value products, any liquid left in a piping system can be costly. We offer a line of sanitary orifices the reduce this risk when a fixed orifice pressure reduction is required in the process. Unlike most orifice plates which can leave some liquid on the upstream side of the plate, the Holland sanitary orifices are fully draining when mounted in the vertical position. The tapered interior design ensures that there will be no product hold up.