The labeling should be clear, easy to interpret and familiar to the users. It can be:
Mechanical labeling is carried out by machines or templates that are produced for this use.
Manual labeling should be done on self-adhesive labels or on the fold or flap of the package, making sure not to perforate the package and that the writing ink does not stain the medical use device.
The medical use product should be identified with the following information:
- Name of the material
- Destination (in the event that it is needed)
- Preparation and/or sterilization date
- Code of the person responsible
- Lot number
- Any other clarification that is considered necessary (expiration date)
Every package should have an exposure control, as well as identification or labeling of the content, service, lot, expiration date and initials of the operator.
Adequate labeling of the package allows for identification of the contents, storage and expiration period. It also enables the tracking of sterilized packages in the event of technical problems with the device or an infectious event that is attributed to deficiencies in the sterilization process.
Adhesive labels or adhesive tape (masking tape), a bar code or a manual label maker can be used.
A registration system for the storage and distribution of articles should be developed and all users should be knowledgeable about the system.
Evaluation of the packaging process
Packages should undergo continuous evaluation in order to confirm the following:
- Integrity of the external layer of the material
- Integrity of the seals
- Correct identification
- Gauge of the chemical indicator
- Reading of the expiration date
The timing and human resources (external auditors) for evaluation of the packaging process should be established.
Tuesday, November 7, 2023
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