Labeling and Packaging Part I

Product packaging and labeling must be treated as an integral part of the medical device itself. Therefore, the product is not completed and could never be released for distribution before it is packaged and all specified labeling and packaging requirements of the quality management system fulfilled. For example products manufacturing must also apply to labeling and packaging as well.

Therefore, any operational procedures and other quality system documentation related to packaging and labeling must be followed, examples are shown below:

Design control, including design validation and control of design output and changes for labeling and packaging;

Control of packaging and labeling processes including personnel training, process

validation, work instructions, process monitoring, and process records;

Inspection and final acceptance of packaging and labeling; and

Establishment and maintenance of necessary records for labeling and packaging.

The following talks about labeling and packaging design and validation. Labeling and packaging design and validation must also be carried out like it is an integral part of the product.

1) Labeling and packaging, and their artwork, are developed in the phase of product design as in any part of the medical device itself. The development processes are implemented in accordance with Operational Procedure for Design Control, to include requirements for design input, design planning, documenting and controlling design output, conducting design reviews, and verifying and validating the labeling and packaging design.

2 ) For example, medical device products to be marketed in the European Union and South Korea, labeling and instructions for use are translated into foreign national languages versions according to the intended plan for placing the product on the respective market. The translation process and the correctness of the translations is undertaken according to the procedures. For examples, translation must be done by qualified translators.

3)  When packaging is designed to meet certain performance requirements, such as sealing the product to protect it from heat, light or contaminants; or structural ability to withstand stacking or shipping loads, the packaging is validated by testing it under actual or simulated conditions of distribution, storage and use. For example, when the medical device is intended to be marketed in a region with high temperature and humidity. The product packaging must be validated again humidity and relative humidity.

4)   Packaging for sterile products is likewise validated to test packaging materials and the seal. There are many types of sterilization techniques such as Wet/steam sterilization, Dry heat sterilization, Ethylene oxide, Sporicidal chemicals, Glass Plasma and Irradiation (Gamma rays).

 

5) Labeling integrity is validated to ensure that labels will remain in place and be legible under normal operating and use conditions. There are many requirements for label like what symbols to use, what font size to use and manufacturing site and expiry are some examples of key information printed on the labels.

Reference	Criteria
ISO 13485: 7.5.5	Has the company established documented procedures or work instructions for preserving the conformity of product labeling during internal processing and delivery to the intended destination?
ISO 13485: 7.5.5	Does this preservation include identification, handling, packaging, storage and protection?
ISO 13485: 7.5.5	Has the company established documented work instruction for the control of product with a limited shelf life or requiring special storage conditions?
ISO 13485: 7.5.5	Are special storage conditions controlled and recorded?
SO 13485: 7.5.5	Have procedures been implemented to ensured, where relevant, that labelling and instructions for use are translated correctly into foreign national languages versions according to the intended plan for placing the product on the market?
ISO 13485: 7.5.5	Is it ensured, where relevant, that requirements for e.g. national language versions are checked and controlled in connection with dispatch, storage, etc.?
ISTA 208, 2A	Is the product withstand all tests stated in the ISTA guidelines
ASTM D 5276-98	Is the product withstand the free fall drop test?
ASTM D 5487-98	Is the product withstand vertical shock test?

Disclaimer: Although the author had exhaustively researched all sources to ensure the accuracy and completeness of the information contained in this blog, but no warranty and fitness is implied. I assumed no responsibility and implied warranty of any kind for errors, inaccuracies, omission, or any inconsistency herein. No liability is assumed for incidental or consequential damages in connection with the use of the information contained herein. Readers should always use their own judgment and review all related regulatory guidelines. Guidelines can change over time.