- June 01, 2002, David J. Bentley Jr., RBS Technologies
Medical packaging has many applications today. They range from a simple unit dose plastic package that might contain two aspirin tablets to a plastic package containing all the tools, devices, medications, etc., necessary to perform a medical procedure in a hospital or doctor's office.
Considering the advances in the field of medicine and the growing population of older people requiring increasing medical care as they age, medical packaging use increases significantly each year.
At first glance, medical packaging would appear to be the same as other types of packaging. Flexible medical packages often use the same substrates as flexible packages that may contain snack foods, meat and cheese products, fresh vegetables, etc. The PE, PP, polyester, foil, paper, and other substrates used in all these packages undergo combination with typical adhesives. These can range from polyacrylates to PUs with many other adhesive possibilities falling between them. They can be single- or multi-component. They can be aqueous systems, solvent systems, high energy curing products, etc.
The same statements also apply to coatings and inks. Similar types of products find use in both standard flexible packaging and in medical packaging applications.
What are the concerns regarding medical packaging from the viewpoint of a converter or a supplier to such a converter? Although such concerns are simple, they are vitally important and require special attention. Everyone involved in medical packaging must be aware of these concerns and have procedures in place to cover them.
The first concern relates to dust, dirt, or contamination. Although any converter or supplier to a converter in the packaging industry should operate in a clean environment, dirt, dust, and contamination are totally unacceptable in medical packaging applications. Consider a small speck of dust or dirt. Many plastic films or webs for medical packaging can develop an electrostatic charge during processing. This charge could attract a speck of dirt or dust and cause it to adhere to the web. The speck might remain on the web through all processing necessary to make and store the medical package. Not until actual use near an open wound on a patient might the speck disengage from the package. If it then entered that wound, the patient might develop an infection.
Composite webs for medical packaging must be thoroughly dry and fully cured. An aqueous adhesive, coating, or ink can't have any retained water in the finished system. Adhesives, coatings, and inks applied from solvent systems cannot have any retained solvent in the finished system. And, no component of a construction may have any unreacted components. This means heat-, UV-, and EB-cured materials can't have any monomers, unreacted chemical entities, oligomers, etc., in the final product.
A chemical material entering a medical package obviously would be a contaminant. The primary worry is the chemical reacting with something in the contents of the medical package.
As in flexible packaging, medical packaging must meet any applicable regulations of the US FDA. Usually, the FDA requires an additional step: Each medical package must provide a Drug Master File to the agency. In this file, the manufacturer of the package discloses the exact composition of all the components to include substrates, adhesives, coatings, inks, etc. This disclosure is confidential.
Having provided the FDA with this information, the converter cannot change anything in the composition of the medical package without advising the regulatory agency. This restriction refers to all components of the package.
In summary, a medical package is not simply a flexible packaging containing something for use in the medical field; a medical package must meet the other issues noted above.
David J. Bentley Jr. is a recognized industry expert in polymers, laminations, and coatings with more than 30 years of experience in R&D and technical service. Contact him at firstname.lastname@example.org.