Application sharing of packaging and sealing machine in medical industry
Primary Applications:
Medical sealers are primarily used for continuous sealing of sterilization pouches, including paper-plastic flat/3D pouches, breathable pouches, PE bags, paper-paper pouches, Tyvek® pouches, and aluminum composite materials. These packages are typically employed for wrapping surgical instruments, medical devices, and other healthcare supplies to maintain their sterility post-sterilization.
Compliance & Standards:
Medical sealers must comply with GMP certification requirements and adhere to international standards such as BS EN ISO 11607:2006 and YY/T 0698-2009, which ensure performance and safety meet stringent medical industry criteria. Additionally, the equipment must accommodate diverse sterilization methods, including high-temperature steam, low-temperature ethylene oxide (EtO), hydrogen peroxide plasma, and radiation sterilization, to guarantee effective sterilization outcomes.
Equipment Variants:
Medical sealers are available in multiple configurations:
- Constant-temperature sealers
- Pulse-type sealers
- Nitrogen-flushing vacuum sealers
These variants cater to different packaging materials and sterilization protocols.
Operational Workflow:
Standard procedures include:
- Powering on the device
- System configuration (e.g., temperature settings, sealing parameters)
- Pre-sealing preparations (e.g., material alignment)
- Label printing setup (if applicable)
- Initiating the sealing process
This workflow ensures operational accuracy and consistent seal quality.
Use Cases:
Widely deployed in hospital CSSDs (Central Sterile Supply Departments), operating rooms, and clinical units, medical sealers are critical for post-sterilization packaging of devices such as:
- Surgical instrument sets
- Syringes
- Catheters
Proper sealing preserves sterility and package integrity throughout storage and transport.
Maintenance Protocols:
Routine upkeep is essential for longevity and reliability:
- Regular cleaning of sealing surfaces
- Calibration checks for temperature/pressure
- Inspection of seal integrity (e.g., peel tests)
- Timely replacement of worn components (e.g., heating elements)
Key Considerations:
- Environmental conditions (humidity, dust control)
- Parameter optimization (temperature, dwell time, pressure)
- Material compatibility (e.g., Tyvek® vs. plastic films)
- Validation for intended sterilization modalities
Conclusion:
Medical sealers play a pivotal role in healthcare by ensuring sterile barrier systems meet regulatory and functional requirements. Their proper selection and operation directly impact patient safety through enhanced sterilization assurance and package reliability, underscoring their indispensability in modern medical practice.
