The Recipe for a Great Product Specification

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A product specification for healthcare packaging manufacturing is like a recipe. It details, step-by-step, the requirements for producing a finished good. Like any good recipe, it ensures that when followed, the final output meets the customer’s quality, performance, and safety needs. It is crucial for medical device customers to understand the various components of a specification to achieve the desired results. Here we break down the top five “ingredients” to a great product specification:  

1

Materials

In a product specification, materials are outlined as well as the right combination. This ensures the supplier creates the right product. All materials must adhere to industry standards and often include proprietary mediums such as adhesive coatings. In addition to material combinations and types, a specification will dictate whether the material should be printed or unprinted, what font, font sizes, barcodes, colors, and type of printing must be used.  
2

Dimensions & Tolerances

The build requirements within a specification focus on the dimensions and tolerances, which are essential for production. Tolerances are based on machine capabilities and tooling requirements to create the finished good. In our case with packaging, features such as tear notches and hang holes in pouches or radius corner values for lids must be clearly defined. Precision is critical in these details as it determines what is needed for creating custom tooling. Additionally, visual representation of the product is critical. Many converters, like Oliver, accept multiple drawing platforms, including CAD files, engineering drawings, and DWG files. 
3

Manufacturing

Manufacturing requirements are also a critical part of the product specification. An example of a manufacturing requirement would be particulate inspection. Many customers have specific particulate inspection criteria and unique cleanliness needs. Typically, this portion of the product specification will detail out the level of ISO rated cleanrooms and, in some cases, get as specific as the cleaning intervals, gowning requirements, and operator protocols that prohibit cosmetics, glitter, nail polish, and other contaminants.  
4

Packaging of Final Goods

Packaging and labeling details of the final goods is also essential. Does the final good need to be packaged in clean bags or double bagged? Where do labels need to be adhered (the bundle, carton, and/or pallet) and what do they need to say? These ensure product protection and offer customizable configurations. Additionally, customer requirements for test data, along with the standard Certificate of Compliance (CoC), should be clarified.  
5

Quality

This portion of the specification outlines what steps are taken to ensure the finished good meets the quality and expectation of the customer. It’s common for test standards to be tailored to align with customer needs. For example, often peel testing  and which test a customer prefers, whether that be a 90-degree unsupported or a 180-degree supported will be called out. Other types of tests include testing for seal creep and burst. All testing must meet customer standards, Oliver standards, and industry standards.  

Lastly, we can’t talk about a great product specification without discussing version control. It is extremely important to the success of any finished good. Many converters work with what is called a “released” specification, meaning that the customer has signed-off on the product specification and cleared it for use. To get to this point though, there can be various reviews between the customer and product specification team.  

 

From build specifications to final shipment packaging the goal is to make customer needs and expectations clear and streamline the process. Just like any recipe, a well-written specification details what is necessary to produce a high-quality product. Each “ingredient” of the specification plays a vital role in maintaining consistency, meeting performance standards, and ensuring compliance with legal and regulatory requirements.  

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