Both regulatory authorities and pharmaceutical industry itself puts great emphasis on manufacturing pharmaceutical products using practices and processes that ensure high levels of quality and safety built into every step.
Pharmaceutical standards help companies involved in developing complex molecules through every stage of their new product development process and lifecycle. Our global pharmaceutical standards enhance your end-to-end manufacturing processes, providing you with the confidence that you are optimizing the time to market, whilst ensuring patient safety.
The top ten most adopted standards in the pharmaceutical sector and their benefits to organizations are as follows:
BS EN ISO 20417:2021 Medical devices. Information to be supplied by the manufacturer.
This international standard details the information that medical device manufacturers should supply with their products. It specifies the information to be supplied by medical device or medical device accessory manufacturers.
It covers general requirements, medical device identification, requirements for packaging, requirements for marking and information on the label, and requirements for accompanying documentation.
BS EN ISO 20417:2021 aims to serve as a central source of these common, generally applicable requirements, allowing each specific product standard or group standard to focus more concisely on the unique requirements for a specific medical device or group of medical devices. The requirements of a medical device product standard or a group standard can make use of these general requirements.
Use of the standard can help medical device manufacturers to comply with the requirements of the MDR, enter new markets, develop their product information expertise, facilitate trade, manage risk and increase trust in their products. It also contributes to UN Sustainable Development Goal 3 on ensuring healthy lives and promoting well-being for all at all ages. This goal looks for the provision of quality healthcare and also of equipment that helps healthcare providers deliver a safe, reliable, and effective service, which is what this standard supports.
BS EN 13726-1:2002 Test methods for primary wound dressings. Aspects of absorbency.
Most wound dressings are applied to remove excess wound fluid (exudate) from the immediate vicinity of the wound.
This part of standard BS EN 13726 specifies test methods recommended for the evaluation of some aspects of absorbency of primary wound dressings. It covers test methods which assess absorbency, fluid handling capacity, and dispersion characteristics of wound dressings.
Adopting this standard means organizations can deliver a safe, reliable, and effective wound dressings, inspiring trust from their clients.
BS 661210:2018 Graduated compression hosiery, anti-embolism hosiery, and graduated support hosiery. Specification.
This standard specifies requirements and test methods for the compression and stiffness of graduated compression hosiery, anti-embolism hosiery, and graduated support hosiery.
The test method in Annex A might also be suitable for assessing the compression of dual-layer compression kits (e.g. ulcer kits) and other tubular compression devices, e.g. arm sleeves. There are some garments for which this test method is not suitable, and where the former settings of the test instrument might not accommodate all potential designs, especially some made to measure garments.
BS EN ISO 17351:2014 Packaging. Braille on packaging for medicinal products.
This standard has been developed to meet requirements for Braille on packaging for medicinal products, and technical constraints and user requirements, to harmonize technical standardization and specifications.
Braille will continue to be an essential means of communication for blind and visually impaired people around the world. Braille labeling is required in Europe by regulation on the outer packaging for medicinal products.
This standard helps pharmaceutical manufacturers ensure they are adopting best practices to comply with regulations and deliver products which are safe to use by every consumer.
BS EN 13726-2:2002 Test methods for primary wound dressings. Moisture vapour transmission rate of permeable film dressings.
Moisture vapour transmission (MVTR) forms an important part of the fluid handling properties of a dressing. It influences both the hydration of the wound and that of surrounding tissues where maceration may be a problem.
This part of standard BS EN 13726 specifies test methods recommended for the evaluation of wound dressings that handle wound exudate through permeability alone when in contact with water vapour and when in contact with liquid.
Adopting this standard means that organizations can deliver safe, reliable, and effective wound dressings, inspiring trust from their clients.
BS EN 14375:2016 Child-resistant non-reclosable packaging for pharmaceutical products. Requirements and testing.
Child-resistant packaging is used to create a physical barrier between a child and a potentially hazardous product. This packaging is vital as it prevents many thousands of domestic traumas of suspected poisoning, minor spills, or ingestions that are non-fatal but nonetheless worrying.
This standard specifies performance requirements and methods of testing for non-reclosable packaging that has been designated child-resistant. It is intended for type approval only and is not intended for quality assurance purposes.
For medicinal packaging manufacturers, adopting this standard helps them to approve packaging types and comply with regulations.
To read more on child-resistant packaging, click here.
BS EN 13726-4:2003 Test methods for primary wound dressings. Conformability.
When a dressing is applied in a region or movement e.g over a joint, it is important that it allows sufficient freedom of movement to avoid damage under the dressing. A dressing that is easily extended and which returns close to its original length after extension will be more comfortable for the patient to wear. An adhesive product that extends sufficiently easily with the skin helps to prevent subcutaneous shearing damage.
This part of standard BS EN 13726 describes methods for measuring aspects of conformability of primary wound dressings. In other words, it is used to check the ability of a dressing to adapt to the shape and movement of the body. This test is designed to assess the extensibility and permanent set conformability of a primary wound dressing by measuring its extensibility and permanent set.
DC14/30300957 (BS EN 16756). Antimicrobial wound dressings. Requirements and test methods.
The effectiveness of antimicrobial agents incorporated into wound dressings is measured by their ability to kill microorganisms within a specified contact time. Consequently, accurate determination of antimicrobial activity requires complete and immediate neutralization of the antimicrobial agent.
Classification of antimicrobial dressings is not presently standardized.
This draft standard specifies requirements and test methods for the antimicrobial activity of antimicrobial wound dressings. It is designed for microbicidal and microbistatic dressings.
Test methods specifically for microbial binding are not included in the standard.
BS EN 13726-3:2003 Test methods for primary wound dressings. Waterproofness.
The ability of a dressing to maintain a waterproof barrier is important to prevent the possible transmission of bodily fluids into the wound. This part of standard BS EN 13726 describes a test method for the evaluation of waterproofness of primary wound dressings when such claims are made.
This test measures the ability of the outer surface of the dressing to act as a waterproof barrier under hydrostatic pressure.
Adopting this standard means that organizations can effectively test their products and ensure they are fit for their purpose.
BS 3221-7:1995 Medicine measures. Specification for oral syringes delivering doses up to and including 5ml.
Oral syringes are used to easily dispense liquid medication to a range of patients. They ensure precise administration of medicines, enhancing patient safety.
This part of standard BS 3221 specifies general design and performance requirements for the size ranges of oral syringes for containing and delivering liquid medicines in measured volumes of up to and including 5ml.
Adopting this pharmaceutical standard means organizations can check the accuracy of their syringe, manage the quality of their product, and protect their clients from risk.
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