As regulations, manufacturing processes, quality control procedures, or products change oftentimes it requires a new label to capture necessary information, communicate status, and endure new environments. Working with a label company that focuses on quality control and the life sciences industry will ensure that your label is designed specifically for your SOP and manufacturing environment.
Understand the operating environment
It is important to first assess the conditions a label will be exposed to in order to design an appropriate custom label. After reviewing the SOP associated with a quality inspection, manufacturing process, storage and distribution, etc. consider the environment that the label travels through and make a list of these conditions.
Important Conditions to Consider:
- What is the label affixed to?
- Will the label need to be removed or permanently adhered?
- What are the temperature extremes (both hot and cold)?
- Will the label be stored in cryogenic conditions?
- What is the application temperature of the label? Will it be applied to a room temperature item or a frozen item? Will the item be wet or have condensate when applied?
- Will the label undergo sterilization such as EtO, autoclave, or gamma radiation? If so, how many cycles?
- Will the label need to be printed or written on?
- Will the label be exposed to harsh chemicals such as xylene or isopropyl alcohol?
Read our blog post on Choosing the Right Label Material to learn more about what to consider when selecting materials for a custom label.
Partnering with the right label manufacturer
It is apparent from the list above that there is a broad spectrum of labels and materials to meet a variety of use cases. It should then become clear that there is a broad spectrum of label manufacturers focused on specific markets. Selecting a label manufacturer that has a deep understanding of the medical device, pharmaceutical, and biotechnology industries and regulations is critical to ensure that a custom label is manufactured that is capable of enduring the conditions common in these environments.
The right label manufacturer will have the expertise to guide you in selecting the right materials, the materials and manufacturing processes available to produce your custom label, and the quality management systems in place to ensure that your custom label is manufactured to meet your specifications repeatedly.
GMP Labeling Inc. has been a label provider for the life sciences industry since 1987. We understand the regulations and quality control procedures that companies in this industry must meet. And our operation is audited annually under ISO 9001:2015 guidelines. We have the expertise, materials, and quality system in place to produce custom labels for your operation.
Testing before implementing
A crucial step in designing and procuring a custom label is to test the label in the actual environment it will be exposed to before implementing its use in your SOP. GMP Labeling can provide samples of label materials to ensure that the label will operate in your specific conditions. This saves time and money while also preventing future quality issues.
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