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Manufacturing of infusion sets: how long does it take to produce them?

infusion set workshp

The lead time is one of the most important aspects that clients care about. It is influenced by several factors such as production time, transportation time, etc. In this article, we will describe production time in depth. The production time is affected by procurement of parts and materials, inspection and warehousing, injection molding and squeezing out the blow, assembling the parts, sealing, packing, sterilization, Analytical, and storage.

Standard workflow in the manufacturing (in-house work)

Here are some steps in the IV set manufacturing process: purchasing raw materials and parts, inspection and warehousing, injection molding and squeezing out the blow, assembling, sealing, packing, sterilization, analytical, and storage.

Procurement of parts and materials

Procurement of parts and materials of IV sets refers to the outsourcing of components and materials needed to produce and assemble the infusion sets. Completed parts, such as rubber bulbs, isoprene pad, and others used in IV sets, come from the company’s suppliers. Raw materials, such as PVC, ABS, and PE needed to produce parts, also come from the company’s suppliers.

Inspection & Warehousing

Before entering the warehouse, the factory will inspect outsourced IV parts and materials. Then the factory will store them in a ventilated and dry place. The parts will be stored in the intermediate warehouse before assembly.

Injection molding and squeezing out the blow

Injection, molding, and squeezing out the blow are manufacturing processes to transform raw materials into completed parts of IV sets. Injection and molding, for example, transform ABS into roller clamps, spikes, and Luer lock connectors. Squeezing out transforms PVC into a drip chamber. After finishing this process, all parts will be inspected and stored in the intermediate warehouse before assembly.

Assembling the parts

The Manufacturer assembles the finished parts to produce the infusion sets by machine and hand. From the picture, you can see how the parts are assembled into the complete drip chambers by machine.

Parts assembled into drip chambers

Sealing

The unit infusion set will be packed into a small PE bag or paper pouch, which will be sealed after due inspection. The small PE bag and paper pouch are the primary packing for infusion sets.

Packaging

After the inspection, infusion sets will be packed into a big PE bag or small box, which calls secondary packing. Finally, all big PE bags or boxes will be packed into the outer carton.

Sterilization

The Manufacturer sterilizes the outer cartons after due inspection and passing the window. Sterilization protects the infusion sets from microorganisms that can cause infections to would-be users. 

Ethylene oxide sterilizer

Analytical

After sterilization, the manufacturer analyzes the finished infusion sets. This process facilitates the dissipation of the toxic ethylene oxide (EO)—used in sterilization—from the finished products. 

Storage

After the required inspection, the manufacturer stores the finished infusion sets and keeps them adequately until company workers deliver them to would-be users.  

Stumbling blocks or delaying factors in the production

Delay in customer’s artwork of packing

The clients have to confirm with the factory about the artwork asap. The delay in artwork will delay the production of packing. Without the packing, production cannot proceed normally.

Delay in paying the customers’ deposits

The manufacturer needs the customers’ deposits to procure the materials and parts required for production. The customer must advance the payment on time to ensure that the manufacturer can buy the necessary materials and components. Otherwise, the manufacturer cannot start production.  

Type of materials to be used

The type of materials used in the production also affects the production period. Specifically, suppose the factory uses non-DEHP PVC. In that case, it requires a longer time because the factory usually does not have stock of this material and needs to buy it from suppliers, who don’t even have stock for some time. Thus, this factor could prolong the production period if prompt delivery fails or the goods are unavailable from external sources. DEHP Free IV set is used for some particular drugs, such as Taxol and Taxotere, which will promote the separation of DEHP from the infusion set and cause toxicities.

Delay in the delivery of materials and parts

Delay in the delivery of needed goods could also prolong the production period. Whoever is responsible for delivering goods to the manufacturing plant must guarantee the prompt and on-time arrival of goods.   

Usual time requirements for principal steps

Production and delivery of packaging materials

Barring all possible delay sources, the production and delivery of the packaging materials will take 2 to weeks. If some delaying factors come into play, it may take more than a month.

Ordering and purchasing parts and materials

After receiving the customer’s deposits, the Manufacturer starts ordering and purchasing parts and materials, which will require from to 2 weeks to accomplish it. 

Production of parts

Production of parts requires 1 week to accomplish. 

Assembly of the parts

The time required for assembling the different parts depends on the number of infusion sets to be prepared and produced.  

Summary of major steps and time requirements

Major ActivitiesMinimum Time RequirementIn WeeksPossible Maximum Time Requirement In Weeks
Reception of customers’ inputs and specifications(1)(2)
Production and delivery of packaging materials23 or more
Reception of customers’ deposit(s)(1)(2)
Ordering and purchasing of parts and materials12
Production of parts11
Assembly of parts and packaging(1)(2)
Total time7 weeks = 49 days12 weeks = 84 days
TABLE 1   Usual time requirements of major activities without delays in column 2 and with possible delays in column 3

Analysis of production time requirements

Without delays, manufacturing infusion sets will take 45-50 days (Table 1, Column 2). If there are delays, it may need a longer time. Two steps are dependent on and highly controlled by the customers:

(1) the confirmation of artwork for packing

(2) the payment of deposits.

If these steps are unduly prolonged, the customer must wait longer as the total production time required to produce infusion sets will also be lengthened. The Manufacturer must refrain from imposing deadlines as these moves may drive away customers. However, the Manufacturer can offer incentives to encourage customers to submit their specifications and deposits as soon as possible.     

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