Packaging Flashcards
Functions of packaging include
- Protection: Packaging is designed to protect the product during transportation, storage, and handling. It can prevent damage from external factors such as moisture, sunlight, temperature, and physical impact.
- Containment: Packaging keeps the product contained and prevents it from spilling, leaking, or becoming contaminated. This is particularly important for products that are liquid or granular.
- Information: Packaging provides important information to the consumer, including the product name, ingredients, nutritional information, usage instructions, and safety warnings. It can also include branding and marketing messages.
What are some of the packaging needs that apply for ETO sterilization?
The packaging needs that apply for ETO sterilization include material compatibility, permeability, seal strength, porosity, labeling, and sterility maintenance.
Why must packaging materials be selected for compatibility with the sterilization process and the devices or products being sterilized?
ETO sterilization can damage or degrade certain types of materials, such as some plastics or rubbers. Therefore, packaging materials must be selected to ensure compatibility with the sterilization process and the devices or products being sterilized.
What is the purpose of labeling the packaging used for ETO sterilization?
The packaging must be clearly labeled with information about the sterilization process, including the date of sterilization, expiration date, and any other relevant information.
Why must the packaging be designed to maintain the sterility of the contents until they are used?
The packaging must be designed to maintain the sterility of the contents until they are used to ensure that the sterilization process is effective, safe, and meets regulatory requirements. The packaging must protect against contamination during storage and handling, and must be easy to open without compromising sterility.
Why is material compatibility important in gamma sterilization packaging?
Material compatibility is important in gamma sterilization packaging because some materials may be damaged or degraded by the sterilization process, which can compromise the safety and efficacy of the product.
What is radiation penetration in gamma sterilization packaging?
Radiation penetration refers to the ability of gamma radiation to penetrate through the packaging material and effectively sterilize the contents of the package.
What is seal strength in gamma sterilization packaging?
Seal strength refers to the ability of the packaging to be sealed tightly to prevent radiation from escaping during the sterilization process. The seal strength must be sufficient to withstand the pressure and temperature changes during sterilization.
What information must be included on labeling for gamma sterilization packaging?
The labeling for gamma sterilization packaging must include information about the sterilization process, including the date of sterilization, expiration date, and any other relevant information.
What is biocompatibility in gamma sterilization packaging?
Biocompatibility refers to the ability of the packaging materials to be in contact with the sterilized product without causing harm or adverse reactions to the patient or user.
Why is material compatibility important in steam sterilization packaging?
Material compatibility is important in steam sterilization packaging because the sterilization process can damage or degrade certain types of materials, such as some plastics or rubbers.
Why must packaging materials be moisture-resistant in steam sterilization?
Packaging materials must be moisture-resistant in steam sterilization because the process involves the use of steam and high humidity, and inadequate moisture resistance can cause damage to the contents.
What is the importance of seal strength in steam sterilization packaging?
Seal strength is important in steam sterilization packaging because the packaging must be sealed tightly to prevent steam from escaping during sterilization, and the seal strength must be sufficient to withstand the pressure and temperature changes during sterilization.
What information must be labeled on steam sterilization packaging?
Steam sterilization packaging must be clearly labeled with information about the sterilization process, including the date of sterilization, expiration date, and any other relevant information.
What is the overall goal of packaging used for steam sterilization?
The overall goal of packaging used for steam sterilization is to ensure that the sterilization process is effective, safe, and meets regulatory requirements, and that the packaging maintains the sterility of the contents until they are used.
What is Tyvek?
Tyvek is a trade name for a bonded, non-woven paper made from synthetic polymer fibers like polyethylene.
Why was Tyvek developed?
Tyvek was developed to meet the growing demand for a multi-purpose material suitable for all types of sterilization.
How is Tyvek often used in packaging?
Tyvek is often used as one side of a pouch, giving strength and stability to the paper back. Alternatively, the Tyvek can be used on both sides creating a virtually tear-free protective pouch, with overlapping chevrons to aid opening.
What are some other uses of Tyvek in medical device packaging?
Tyvek is also used for lids on semi-rigid assemblies, and it is probably the best option for peelable lids but is comparatively expensive.
Why has the use of Tyvek in medical device packaging continued to increase?
The use of Tyvek has continued to increase indicating that medical device manufacturers recognize a need for tougher and better-sealed lids and will pay more for these features.
When might plain seals provided by paper lidding be a cost-effective alternative to Tyvek?
If costs are critical, particularly with disposables, or volumes are low then plain seals provided by paper lidding may well be the cost-effective alternative.
Can paper still provide an effective seal and peel strength for medical device packaging?
Yes, paper can still provide an effective seal and peel strength with a suitable adhesive and can be reinforced if necessary.
What happens to the paper during sealing equipment?
At normal speed, the sealing equipment causes heating of the paper of at least 10°C.
How does the peel method work for paper lidding?
The adhesive is engineered to ensure that the seal splits and not the paper, as shown in the diagram.
What are some of the challenges sterile medical device packages face during transportation?
Sterile medical device packages face challenges such as vibration and shock, temperature fluctuations and humidity changes, and variation in atmospheric pressure during transportation.
Why are sterile medical devices transported by road, air, sea, and rail?
Sterile medical devices are transported by road, air, sea, and rail to reach their final destination. They may need to travel long distances and be shipped overseas, so different modes of transportation are necessary to ensure they reach their destination.
What happens to pallet loads of sterile medical devices during transportation and distribution?
Pallet loads of sterile medical devices are broken down into smaller units for stacking on shelves in distribution warehouses. They are then picked off the shelves to assemble mixed product loads that meet customer needs.
How do temperature fluctuations and humidity changes affect sterile medical device packages during transportation?
Temperature fluctuations and humidity changes can affect sterile medical device packages during transportation by causing damage to the package or contents. These changes can cause condensation, which can lead to moisture damage or contamination.
