Collection: Medical Sealers
Definition and Importance
Understanding the role of medical sealers in healthcare and pharmaceutical sectors.
Medical sealers play a crucial role in the healthcare and pharmaceutical sectors by ensuring the sterility and safety of medical devices, instruments, and equipment. These machines are designed to seal medical packaging materials, such as plastic, paper, and foil, to prevent contamination and maintain the quality of medical products. By creating airtight and secure seals, medical sealers help to protect the contents from external factors that could compromise their integrity.
This is essential in various applications, including sterilisation, packaging, and labelling, where maintaining a sterile environment is paramount. Medical sealers are used in hospitals, clinics, and laboratories to ensure patient safety and prevent the growth of microorganisms, thereby playing a vital role in the overall healthcare system.
Types of Medical Sealers
Overview of various medical sealers and their specific uses.
There are several types of medical sealers, each designed for specific uses and applications. Hand sealers are manual devices ideal for small-scale sealing operations, offering precision and control for delicate tasks. Pouch sealers, on the other hand, are specifically designed for sealing medical pouches and bags, ensuring a secure and sterile seal for various medical supplies. Machine sealers are automated devices capable of sealing large quantities of medical packaging materials quickly and efficiently, making them suitable for high-volume operations. Additionally, impulse sealers use a brief pulse of electricity to create a seal, while heat sealers apply consistent heat to bond materials together. Ultrasonic sealers utilize high-frequency vibrations to generate heat and create a seal, offering a unique solution for specific medical packaging needs. Each type of sealer has its unique features and applications, catering to the diverse requirements of the healthcare and pharmaceutical sectors.
Key Properties and Materials
Essential characteristics and materials used in medical sealers.
Medical sealers are designed with specific properties and materials to ensure their safety and effectiveness. These machines are typically constructed from stainless steel or other durable materials that can withstand high temperatures and harsh cleaning agents, ensuring longevity and reliability. Advanced temperature control systems are a critical feature, allowing for precise regulation of sealing temperatures to achieve consistent and reliable results. Medical sealers also often include automatic feeding and cutting systems, enhancing efficiency and accuracy in the sealing process. The materials used in medical sealers, such as latex-free compounds and biocompatible materials, are carefully selected to meet stringent medical standards and regulations, including FDA USP Class VI and ISO 10993 test protocols. These properties ensure that medical sealers can perform their tasks effectively while maintaining the highest standards of patient safety and product integrity.
Medical Device Packaging
The role of medical sealers in ensuring safe and effective packaging of medical devices.
Medical device packaging is a critical aspect of ensuring the safety and effectiveness of medical devices. Medical sealers are indispensable in this process, providing a secure and sterile seal that prevents contamination and maintains the integrity of the device. By creating airtight seals, these machines help to prevent the growth of microorganisms, ensuring that medical devices remain safe and effective until they are used.
Medical sealers are designed to meet stringent industry standards and regulations, such as ISO 11607-1 and DIN 58953 part 7. These standards ensure that medical sealers produce consistent and reliable seals that meet the rigorous requirements of medical device packaging. This consistency is crucial in maintaining the quality and safety of medical devices, which directly impacts patient safety.
In addition to preventing contamination, medical sealers play a vital role in preventing medical errors. A secure and sterile seal ensures that medical devices are used correctly and safely, reducing the risk of errors that could compromise patient health. Overall, medical sealers are essential in the packaging process, ensuring that medical devices are safe, effective, and ready for use when needed.
Machine Architecture and Calibration
Understanding the design and calibration of medical sealing machines for optimal performance.
The architecture of medical sealing machines is meticulously designed to ensure they provide consistent and reliable seals, meeting the high standards required for medical device packaging. These machines typically consist of a heating element, a sealing jaw, and a sophisticated control system. The heating element generates the necessary heat to melt the packaging material, while the sealing jaw applies the precise pressure needed to create a secure seal. The control system regulates both temperature and pressure, ensuring the sealing process is consistent and reliable.
Calibration is a critical aspect of maintaining the performance of medical sealing machines. It involves adjusting the machine’s temperature and pressure settings to ensure that the seals produced meet the stringent requirements of medical device packaging. Regular calibration is essential to maintain the accuracy and reliability of the sealing process, ensuring that each seal is consistent and meets industry standards.
In addition to calibration, regular maintenance is crucial for optimal performance. This includes cleaning and lubricating the machine’s components and replacing any worn or damaged parts. By understanding the design and calibration of medical sealing machines, operators can ensure that these devices perform at their best, producing reliable seals that meet the high standards of medical device packaging.
Our range of Medical Sealers are built to the high standards required in the healthcare & pharmaceutical sectors.
As one of the most fundamental parts of our life healthcare is receiving a unprecedented level of investment both from individuals and organisations.
During the past several years industry standards have been developed in the sector to standardise best practice and technique, relying on a diverse range of heat sealers, compact medical sealers, and other sealing machinery.
Standards for Medical Sealers and Patient Safety
The global packaging standard for terminally sterilised medical devices primarily focuses around EN 868. Here all packaging systems and materials must conform with the standards set it section 1. Part 2 to 10 focuses on testing procedures for the various packaging materials used.
Preceding this the ISO 11607 has been used as an international standard for a number of years. Titled ‘packaging for end-sterilised medical products’ it was combined in 2002 with EN868-1. This has led to joint revision of BS EN ISO 11607 both part 1 & 2 to form the new BS EN ISO 11607 package validation testing standards.
Part 1 of the revised standard is about requirements and test procedures for packaging materials. Wheres part 2 focuses on the Validation requirements and packaging processes.
This new standard states that all packaging processes must be validatable. Also that validation is required to be a replica-table process.
Advanced technologies and processes in the manufacturing of high-quality sealing machines and medical device packaging solutions are crucial. These technologies ensure that the machines are reliable and meet various manufacturing needs, including ISO certifications.
For the continuous band sealing of sterile bags and packaging our range of Hawo heat sealing machines are validatable and will produce optimal seals every time you seal a package. All our medical sealers have built in parameter controls which will monitor acceptable parameters and block the machines operation when they are outside of these.
The HM 850 DC-V and HM 950 DC-V NanoPak medical pouch heat sealer are suitable for projects where packaging must be sealed according to EN ISO 11607-1:2009, EN 868-4:2009 & EN 868-5:2009. These advanced machines are designed for the sealing of pouches and reels (SBS Sterile Barrier Systems) in hospitals (CSSD), medical or healthcare environment.
For vacuum bag sealing or air extraction/purging work see our HV range of both sealers and degassing chambers.
We offer calibrations services from an accredited laboratory to ensure the sealers are accurate.
Our validatable heat sealers are market leading and a important tool helping your organisation to meet its regulatory obligations.
For more information on our wide range of medical heat sealers, don’t hesitate to get in touch with our experienced team today!
For more medical device sealing advice and FAQ’s visit our knowledge base for troubleshooting and answers to common questions.
Medical Sealer Maintenance and Calibration
Best practices for maintaining and calibrating medical sealers to ensure reliability and safety.
Regular maintenance and calibration of medical sealers are essential to ensure their reliability and safety. Here are some best practices to follow:
- Regular Cleaning: Keeping the medical sealer clean is crucial to prevent contamination and ensure optimal performance. Use a soft cloth and mild detergent to clean the sealer, and make sure to remove any debris or residue that could affect its operation.
- Lubrication: Regular lubrication of the sealer’s components is necessary to ensure smooth operation and prevent wear and tear. Use a food-grade lubricant to lubricate the components, and remove any excess lubricant to avoid contamination.
- Calibration: Calibration is vital to ensure that the sealer produces a consistent and reliable seal. Perform calibration regularly, adjusting the temperature and pressure settings as needed to meet the requirements of medical device packaging.
- Replacement of Worn or Damaged Parts: Regularly inspect the sealer’s components for any signs of wear or damage. Promptly replace any worn or damaged parts to maintain optimal performance and prevent contamination.
- Training and Support: Ensure that medical sealer operators receive regular training and support. Operators should be familiar with the sealer’s operation, maintenance, and calibration procedures. Providing ongoing support helps maintain the reliability and safety of the sealing process.
By following these best practices, operators can ensure that medical sealers remain reliable and safe, producing consistent and reliable seals that meet the stringent requirements of medical device packaging.
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Hawo HM 460 AS-V & HM 660 AS-V Validatable Impulse Sealers
Regular price £0.00 GBPRegular priceUnit price / per£0.00 GBPSale price £0.00 GBPContact us for a quote -
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Hawo HV 321 K-V MediVac Next Generation Vacuum Chamber Sealer
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Hawo HV 460/660/800/1100/1300 AP2/4-V Next Generation High Performance Impulse Vacuum Sealer Clean Room Compatible Air Purity Class 6 / ISO 14644-1
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Hawo HPL 450, 630 & 1000 AS Bar Sealer Foot Operated Impulse Sealer
Regular price From £1,584.80 GBPRegular priceUnit price / per£1,630.80 GBPSale price From £1,584.80 GBPOffer -
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Hawo HM 950 DC-V NanoPak® Medical Pouch Heat Sealer
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Hawo® HPL 500 D-V & 3000 DC-V Rotary Heat Sealer
Regular price £3,132.70 GBPRegular priceUnit price / per£3,223.50 GBPSale price £3,132.70 GBPOffer
Knowledge Base
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Learning From Brands Like Ben & Jerry’s, Newman...
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PEFC, the Programme for the Endorsement of Forest Certification, will be a participant at the upcoming Packaging Innovations show in London on September 16th and 17th. The organization will showcase...
Benefits of Sustainable Sourcing will be Promot...
PEFC, the Programme for the Endorsement of Forest Certification, will be a participant at the upcoming Packaging Innovations show in London on September 16th and 17th. The organization will showcase...
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In the demanding world of medical and healthcare, ensuring the sterility and shelf life of combination medical devices is paramount. This requires high-performance, sophisticated packaging materials that act as effective...
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