下一代干式快速接頭功能創新的球閥設計，使液體輸送在制藥應用更高效
Next-generation Dry Disconnect Coupling feature an innovative ball-valve design that enables the optimization of liquid transfer in pharmaceutical application.
- by David Gibble, Product Manager, Chemical & Industrial Business Unit, for OPW Engineered Systems

建立一個成功的制藥生產運營的關鍵，可能就如同堅持一對熟悉的、由來已久的陳詞濫調：“寧安全不后悔”和“時間就是金錢”一樣基本。把一種藥品的終產品從研發實驗室拿到消費者手中并不容易，但如果處理的原材料和終產品中有許多必須包含或必須包含，揮發性或危險化合物在安全的同時，遵循一個簡化的生產計劃，可以大限度地從盈利的窗口的回報。

The keys to establishing a successful pharmaceutical-manufacturing operation may be as basic as adhering to a pair of familiar, time-honored clichés: “better safe than sorry” and “time is money.” Sure, taking a pharmaceutical end product from the R&D lab to the hands of the consumer isn’t easy, but the process can be optimized if the raw materials and end products that are handled—many of which necessarily are, or must contain, volatile or hazardous compounds—are done so safely while simultaneously following a streamlined manufacturing schedule that can maximize the returns from profitable patent windows.

然而，要在醫藥制造領域找到涅盤，需要簡潔可靠地完成許多具體步驟。在這個過程中轉移液體。有許多轉運點，從原材料通過卡車或軌道車到達制造廠開始，然后通過各種管道和切換歧管，便于儲存、加藥、混合、混合、搬運、裝瓶，以及構成生產和供應鏈許多環節的包裝階段。

Finding that nirvana in pharmaceutical manufacturing space, however, requires a lot of specific steps to be completed succinctly and reliably. Take the transfer of liquids in the process. There are many transfer points, starting when raw materials arrive at the manufacturing facility via truck or railcar, then through the various piping and switching manifolds that facilitate the storage, dosing, blending, mixing, tote-filing, bottling, and packaging stages that make up the many links in the production and supply chain.

在整個液體轉移過程中，制藥企業希望優化兩個關鍵問題：生產人員和環境的安全以及完成制造過程所需的時間。

Throughout the liquid-transfer processes, pharmaceutical manufacturers are hoping to optimize two critical things: the safety of production personnel and the environment and the time needed to complete the manufacturing process.

確保人身和環境安全非常重要，因為制藥生產中使用的許多原材料可能是揮發性、危險性或腐蝕性化合物，如甲苯、二氯甲烷、氨、不同的泥漿和鉀鹽，例如，它們必須被適當地控制。畢竟，制藥企業之間有句俗話：“每家制藥廠不過是一家化工廠。”

Ensuring personal and environmental safety is important because many of the raw materials used in pharmaceutical manufacture can be volatile, hazardous, or corrosive—compounds such as toluene, dichloromethane, ammonia, different slurries, and Syltherm, for example—so they must be properly contained. After all, there is a common saying among pharmaceutical manufacturers: “every pharmaceutical plant is nothing more than a chemical plant.”

此外，防止溢出或泄漏至關重要，因為任何發生的事件，除了在不同程度上具有危險性外，還可能中斷生產進度，這不僅會延遲產品完成，還會導致高價值的損失，昂貴的原料和高昂的清理費用。

Additionally, preventing spills or leaks is vital because any that occur, besides being dangerous on various levels, have the potential to interrupt the production schedule, which not only delays product completion, but can also lead to the loss of high-value, expensive ingredients and the incurrence of prohibitive cleanup costs.

Pharmaceutical manufacturing requires the precise handling and dosing of both high-value and hazardous raw materials and end products, necessitating the need for dry disconnect coupling technology that provides a consistent flow rate with little chance of product spills or leaks. The Epsilon Dry Disconnect Coupling from OPW Engineered Systems meets those needs thanks to its innovative ball-valve design.制藥制造需要對高價值和危險的原材料和終產品進行精確的處理和加藥，因此需要采用干式斷開連接技術，這種技術能夠提供一致的流速，而產品泄漏或泄漏的可能性很小。Epsilon干式快速接頭，opw工程系統滿足這些需要，感謝其創新的球閥設計。

制藥制造需要對高價值和危險的原材料和終產品進行精確的處理和加藥，因此需要采用干式斷開連接技術，這種技術能夠提供一致的流速，而產品泄漏或泄漏的可能性很小。Epsilon干式快速接頭，opw工程系統滿足這些需要，感謝其創新的球閥設計。

Pharmaceutical manufacturing requires the precise handling and dosing of both high-value and hazardous raw materials and end products, necessitating the need for dry disconnect coupling technology that provides a consistent flow rate with little chance of product spills or leaks. The Epsilon Dry Disconnect Coupling from OPW Engineered Systems meets those needs thanks to its innovative ball-valve design.

OPW Epsilon low-spill dry disconnect coupling Video

Taking the Plunge

多年來，當制藥商正在尋找一種干式斷開技術時，一種特定類型的技術已經成為主流，這種技術將在液體轉移過程中連接到卡車、軌道車、歧管和管道上的各種軟管。這種技術被稱為“卡口和柱塞”或“提升閥”式連接器。Over the years, a certain type of technology has risen to the fore when pharmaceutical manufacturers are looking for a dry disconnect technology to implement with the various hoses that will be attached to trucks, railcars, manifolds, and pipes during the liquid-transfer process. This technology is referred to as either a “bayonet-and-plunger” or “poppet” style coupler.

卡口柱塞式干式斷開車鉤技術由于其設計和使用對用戶有諸多好處而得到了認可。重要的是，當連接器斷開時，液體損失相對較小，僅為0.5毫升（ml），或相當于1/10茶匙（約0.017盎司）的液體。它們通常還配有安全鎖，以防止流體流過連接器時連接器意外打開。The bayonet-and-plunger dry disconnect coupler technology has gained acceptance because its design and operation possesses a number of benefits for the user. Most important, there is relatively little fluid loss when the coupler is disconnected, as little as 0.5 milliliter (ml) of fluid, or the equivalent of 1/10th of a teaspoon, which is approximately 0.017 of an ounce. They are also generally equipped with safety locks that prevent the coupler from opening accidentally as fluid is flowing through it.

大多數品牌的卡口和柱塞耦合器重量輕，易于操作，消除了操作人員的操作應力和應力。它們的低成本也使它們對那些希望精簡資本成本并保護運營底線的制造商具有吸引力。Most brands of bayonet-and-plunger couplers are lightweight and easy to maneuver, which eliminates undo operational stress and strain on the operator. Their low cost also makes them attractive to manufacturers who are looking to streamline capital costs and protect the operation’s bottom line.

盡管如此，卡口和柱塞連接器確實具有一些負面的操作特性，這使得它們無法成為制藥應用中的干式斷開耦合器技術選擇。首先，雖然在斷開過程中可能會損失極少量的油液，但也有其他耦合技術會損失較少的油液。With all that being said, bayonet-and-plunger couplers do have a number of negative operational characteristics that prohibit them from being the absolute best dry disconnect coupler technology choice in pharmaceutical-manufacturing applications. First, while an extremely small amount of fluid may be lost during disconnection, there are other coupler technologies that will lose lesser amounts of fluid.

從操作的角度來看，卡口和柱塞連接器的不足是其設計，它使許多內部零件與流體直接接觸。任何類型的流量限制都會對生產過程產生負面影響。例如，如果工程師指定了一條2“管線，并且安裝了帶有2”內徑的卡口和柱塞連接器，實際上，流量將小于從自由流2“管線預期的流量，因為液體必須圍繞其接觸的連接器部件工作。這也可能需要一個大于所需的2.5“和3”耦合器。

From an operational standpoint, the biggest shortfall of bayonet-and-plunger couplers is their design, which puts a number of internal parts in direct contact with the fluid flow. Any type of flow-rate restriction will negatively affect the production process. For example, if an engineer specifies a 2” line and a bayonet-and-plunger coupler with a 2” I.D. is installed, the flow rate will actually be less than what is to be expected from a free-flow 2” line because the liquid will have to work its way around the coupler parts that it comes into contact with. This may also necessitate the need for a larger-than-necessary 2.5” and 3” coupler.

此外，卡口和柱塞連接器的內部組件，如彈簧、導向器和提升閥，也會產生液體聚集和隱藏的區域，這使得清潔管路和保持衛生的泵送環境變得困難。Additionally, the bayonet-and-plunger coupler’s internal components, things such as springs, guides and poppets, can also create areas where the liquid can collect and hide, which makes it difficult to clean the lines and maintain a sanitary pumping environment.

當制造商選擇采用閉環流體輸送系統時，刺刀和柱塞耦合器可能處于不利地位，而閉環流體輸送系統在制藥生產過程中正變得越來越流行。缺點是，在一個閉環系統中，可能會有許多閥門展開，這意味著在某一點上，兩個閥門的關閉將使產品困在關閉閥門之間的軟管中。下游閥門隨后打開時產生的壓力有可能損壞前面的連接器，從而導致泄漏和產品泄漏。Bayonet-and-plunger couplers can be at a disadvantage when manufacturers choose to incorporate a closed-loop fluid-transfer system, which is becoming more popular in pharmaceutical-manufacture processes. The drawback is that in a closed-loop system there may be numerous valves deployed, meaning that at some point the closing of two valves will leave product trapped in the hose between the closed valves. The pressure that is created when the downstream valve is subsequently opened has the potential to damage the coupler ahead of it, which can lead to leaks and product spills.

后，由于卡口和柱塞耦合器包含的零件數量較多，因此很難在線維修或維護。事實上，許多卡口和柱塞供應商要求拆下連接器并將其退回制造商進行維修。如果車鉤可以在現場維修，所需步驟的數量和要考慮的零件數量可能會使維修技師感到困難或困惑。Lastly, bayonet-and-plunger couplers are harder to repair or maintain inline because of the number of parts they contain. In fact, many bayonet-and-plunger suppliers require the coupler to be removed and returned to the manufacturer for repairs. If the coupler can be repaired in the field, the number of steps required and number of parts to consider can make it difficult or confusing for the maintenance technician.

Caption: The unique ball-valve operation of the OPW Epsilon Dry Disconnect Coupling allows a convex ball to seat with a concave ball when the valve is opened, in the process creating a straight-through flow path with no cavities or crevices where product can rest. Conversely, the design of traditional poppet-style dry disconnects allows a small amount of liquid to be trapped during disconnection, which can lead to spills that can be harmful to site personnel and the environment.描述：OPW Epsilon干式斷開接頭的獨特球閥操作允許在閥門打開時凸球與凹球一起落座，在這一過程中，形成了一條無空腔或裂縫的直通流道，產品可在此處停留。相反，傳統的提升閥式干式斷開裝置的設計允許在斷開期間截留少量液體，這可能導致泄漏，對現場人員和環境有害。

描述：OPW Epsilon干式斷開接頭的獨特球閥操作允許在閥門打開時凸球與凹球一起落座，在這一過程中，形成了一條無空腔或裂縫的直通流道，產品可在此處停留。相反，傳統的提升閥式干式斷開裝置的設計允許在斷開期間截留少量液體，這可能導致泄漏，對現場人員和環境有害。Caption: The unique ball-valve operation of the OPW Epsilon Dry Disconnect Coupling allows a convex ball to seat with a concave ball when the valve is opened, in the process creating a straight-through flow path with no cavities or crevices where product can rest. Conversely, the design of traditional poppet-style dry disconnects allows a small amount of liquid to be trapped during disconnection, which can lead to spills that can be harmful to site personnel and the environment.

A Better Solution 更好的解決辦法

多年來，卡口式和柱塞式干式斷開耦合器在醫藥制造業的應用中取得了令人欽佩的成績，但一種新型干式斷開耦合器技術已經出現，它能夠克服在提升式耦合器中發現的缺點。下一代耦合器技術通過創新的雙球閥設計，而不是卡口和柱塞。While bayonet-and-plunger dry disconnect couplers have performed admirably in pharmaceutical-manufacturing applications over the years, a new dry disconnect coupler technology has emerged that is able to overcome the shortcomings found in poppet-style couplers. This next-generation coupler technology operates via an innovative double-ball-valve design, rather than bayonet-and-plunger.

該設計的特點是一個凸球位于凹球內，從而消除了兩半配合之間的任何空腔，并保證不會有殘留液體被困在那里，降低了溢出的風險，使液體幾乎沒有地方收集或隱藏，方便清潔，提高衛生操作水平。具體地說，斷開連接后，在連接器的密封面上留下的液體少于0.5毫升，少于淚滴的四分之一。The design features a convex ball that rests in a concave ball, resulting in the elimination of any cavity between the mating halves and guaranteeing that no residual fluid will be trapped there, lowering the risk of spills and giving the liquid virtually no place to collect or hide, which eases cleaning and raises the level of sanitary operation. Specifically, upon disconnection, there will be less than 0.5 ml of fluid left on the face seal of the coupler, an amount that is less than one-quarter of a teardrop.

球閥的設計還包括多個安全聯鎖裝置，允許閥門僅通過用戶的故意操作打開和關閉。這樣可以防止閥門意外打開，從而降低意外泄漏和災難性化學品泄漏的風險。這不僅在從大型儲存容器中轉移原材料時是至關重要的，而且在作為藥品制造的主要原料的許多手提袋填充操作中也是如此。這種小容量容器的恒定開、關充可以消除耦合器上的應力，但球閥的設計和操作方法消除了有害影響。The ball-valve design also incorporates multiple safety interlocks that allow the valve to open and close only through a deliberate action by the user. This prevents any accidental opening of the valve, which lowers the risk of unintentional spills and catastrophic chemical releases. This is not only critical when transferring raw materials from large storage vessels, but also during the numerous tote-filling operations that are a staple of pharmaceutical manufacture. This constant on-and-off filling of smaller-capacity vessels can put undo strain on the couplers, but the ball-valve design and method of operation nullify the harmful effects.

這些新的耦合器可以幫助提高安全性的另一種方法是，事實上，耦合器的表面密封（在符合fda標準的tfm或pda中提供）比競爭技術更耐磨。任何落在密封件上的砂礫、污垢或微粒都有可能留下劃痕，劃痕可能會造成泄漏路徑。由于端面密封具有較高的耐磨性，因此形成劃痕引起泄漏路徑的可能性小。Another way these new couplers can help improve safety is found in the fact that the coupler’s face seal—which is available in FDA-compliant TFM or PDA—is more resistant to abrasion than competitive technologies. Any grit, dirt, or particulates that get on the seal have the potential to leave scratches, with the scratches capable of creating leak paths. Because the face seals have a higher level of abrasion resistance, the chance of scratch-induced leak paths being formed is minimized.

球閥的設計也創造了一個不受限制的流動路徑，使壓降小化，在150加侖/分鐘（568升/分鐘）的流速下，壓降小于1 psi。換言之，需要2“軟管的液體輸送系統可以使用2”球閥耦合器模型，而無需降低或限制所需的流量。The ball-valve design also creates an unrestricted flow path, which minimizes pressure drop and results in less than 1 psi in pressure drop at a flow rate of 150 gallons per minute (568 liters per minute). In other words, a liquid-transfer system that calls for a 2” hose can utilize a 2” ball-valve coupler model without any reduction or restriction to the required flow rate.

與卡口式和柱塞式相比，這種新型球閥連接器的終優點是易于維護。由于其零部件比競爭對手的技術少，所以球閥車鉤的現場維修非常容易，無需將車鉤退回廠家或現場維修人員，與復雜而混亂的維修或保養說明書作斗爭。The final benefit of the new ball-valve coupler when compared to its bayonet-and-plunger cousins is its ease of maintenance. Because it has fewer parts than competitive technologies, the ball-valve coupler can be repaired on-site very easily, with no need to return the coupler to the manufacturer or in-the-field repair personnel to battle with complicated and confusing repair or maintenance instructions.

The unrestricted flow path of the OPW Epsilon Dry Disconnect Coupling enables pharmaceutical manufacturers to experience optimized loading and unloading times.

Conclusion

實現安全操作和成本效益是制藥企業面臨的一項日常挑戰，尤其是當所用原材料既危險又昂貴時。由于許多生產作業需要大型罐區，每天要轉移數千加侖的原材料和終產品，因此使用的干式斷開耦合器的類型以及該技術優化安全性和成本的能力是一個關鍵問題。Achieving safe operation and cost-effectiveness is a day-to-day challenge for pharmaceutical manufacturers, especially when the raw materials used are both hazardous and expensive. With many production operations requiring large tank farms and the transfer of thousands of gallons of raw materials and end products on a daily basis, the type of dry disconnect coupler used, and the technology’s ability to optimize safety and cost is a critical concern.

雖然傳統的耦合器技術已被證明能有效地滿足液體輸送的基本需求，但通過使用新一代技術，如球閥干式斷開耦合器，這一過程可以提升到下一個層次。這項技術提供了可靠、安全、無泄漏的產品控制、全流量能力、法規遵從性以及易于維修和維護的操作優勢，使制藥商能夠滿足其安全和及時生產的需要。While legacy coupler technologies have proven to be effective in meeting the basic needs of liquid transfer, the process can be taken to the next level with the use of a next-generation technology like the ball-valve dry disconnect coupler. This technology provides the operational advantages—reliable, safe, and leak-free product containment; full-flow capability; regulatory compliance; and ease of repair and maintenance—that will enable pharmaceutical manufacturers to meet their needs regarding safety and timely production.

About the Author

David Gibble is Product Manager, Chemical & Industrial Business Unit, for OPW Engineered Systems, part of Dover Corporation’s OPW division. He can be reached at (800) 547-9393 or dgibble@opw-es.com. OPW is the global leader in fully integrated fluid-handling, management, monitoring, and control solutions for the safe and efficient handling of critical petroleum-derived fluids from the refinery to the commercial and retail points of consumption, including loading systems, rail and transport tank-truck equipment, tank-gauging equipment, and automated fuel-management systems, valves and fittings, underground and aboveground storage-tank equipment, spill containers, overfill-prevention devices, secondary-containment sumps and flexible piping, fuel-dispensing products, including swivels, breakaways, industrial and automatic dispensing nozzles for vapor recovery, gasoline, diesel and alternative fuels, and clean energy fueling nozzles and accessories for LPG, Hydrogen and CNG. OPW also manufactures automated vehicle wash systems. OPW has 1,650+ employees with manufacturing operations in North America, Europe, Brazil, China, and India and sales offices around the world. OPW is an operating company within the Fluids segment of Dover Corporation (NYSE: DOV).

Epsilon適用于危險性流體疏松的壓降小的干式快換接頭
Epsilon低泄露接頭系統

EPSILON是一種經過精密安全設計的基于雙球閥系統的低泄露接頭。除了擁有球形閥設計所具備的共有優點之外，EPSILON接頭還為管路連接中的流體提供一條自由流動通道，并且在接頭連通時具有雙重鎖緊功能，增加系統的可靠性。EPSILON接頭系統是為了用于避免化學制品的泄漏和減少揮發性有機化合物（VOC）的散逸性排放，尤其是在過程設備中和槽車裝卸過程中。EPSILON化學制品存儲系統可以為你的工廠在化學制品的輸送過程提供更適應的工藝流程，如改善人員的安全性和降低環境污染的風險，并為您減少總的資金花費和降低運行成本。

EPSILON快換接頭特點

- 提供3/4”, 1”, 1-1/2”, 2” 和3”規格
- 提供不銹鋼和Hastelloy材質
- 適用的接口標準為ANSI美國標準和DIN歐洲標準。
- 符合標準的密封材料，TFM
Next generation PTFE with best combination of temperature ranging from -22°F (-30°C) to 450°F (230°C), sealing, and sliding characteristics.
- 設計的大工作壓力為435 psi（30Bar），高溫度可達450°F（230°C）
- 彈簧操動并加載的TFM或PFA U型杯密封結構
A spring-energized stem and face and flange seal provide initial sealing. The spring supplies all the load required for sealing when the media pressure is too low to fully actuate the lips of the seal. Testing confirms the low spillage and emission specifications are still achieved after 2,000 cycles.
- 聚氨酯防塵罩或不銹鋼承壓蓋帽
Used to protect the ball from damage and debris when coupling is closed and disconnected.
- 外螺紋和內螺紋凸耳/法蘭聯接面
Ramped lug and flange interfaces are first aligned and then connected with a push, followed by a quarter (90°) turn. This “instant” connection method is done by hand without tools in order to create compression on the critical interface seal.
- 獨立、多級安全聯鎖裝置
EPSILON technology involves five independent and redundant mechanical interlocks. They require deliberate sequential action by users, thereby eliminating unintentional spills and catastrophic chemical releases that threaten worker safety and the environment.
- 經多家國際機構批準可用于各種承受壓力的用途