绝缘器手套的质量风险管理
Andreas Kindscher1, Richard Denk2, Chris Burns3
1SKAN Deutschland GmbH, Germany; Andreas.Kindscher@de.skan.ch.
PDA journal of pharmaceutical science and technology
|June 16, 2025
概括
防止隔离手套的污染需要控制措施的组合,而不是单一的行动. 有效的手套质量风险管理对于无菌制药生产至关重要.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 质量风险管理 质量风险管理
- 微生物污染控制 微生物污染控制
背景情况:
- 屏障系统中的手套损坏会造成颗粒物或微生物污染的风险.
- 评估和最大限度地减少与手套相关的特定风险对于产品安全至关重要.
研究的目的:
- 描述控制措施,以减少与隔离器手套损坏相关的风险.
- 强调需要采用多方面的方法来预防污染.
- 突出质量风险管理在确保无菌药品生产中的作用.
主要方法:
- 分析和评估与手套相关的特定风险.
- 实施控制措施,包括功能使用观察,人员培训和监测.
- 手套处理和使用的文件和风险评估.
主要成果:
- 单一的控制措施不足以减轻隔离器手套的污染风险.
- 预防措施的组合是必要的,以有效地降低风险.
- 手套质量风险管理是回答有关污染风险值问题的关键.
结论:
- 全面的质量风险管理对于安全处理和使用隔离手套至关重要.
- 综合控制策略,包括培训和监测,对于防止污染至关重要.
- 了解手套的完整性和潜在的漏洞点对于无菌药品制造至关重要.
相关概念视频
PPE Use in Healthcare Settings II: Doffing
1.2K
The sequence of removing or doffing PPE starts with the gloves, as they are the most contaminated. Next is removal of the face shield or goggles, as they would interfere with removing other PPE. Then remove the gown, followed by the mask or respirator. Perform hand hygiene between steps if hands become contaminated and immediately after removing all PPE. Generally, the outside front and sleeves of the isolation gown, the goggles or the mask, the respirator, and the face shield are contaminated.
1.2K
Standard Precaution
2.2K
Standard precautions are the minimum infection control safeguards used while caring for all patients, irrespective of their disease condition. They help prevent the spread of common infectious microorganisms to healthcare workers, patients, and visitors in all healthcare settings.
Hand hygiene is the most crucial means to prevent the transmission of disease. Employers are legally required to provide their workers with personal protective equipment (PPE) to minimize exposure or contact with...
Hand hygiene is the most crucial means to prevent the transmission of disease. Employers are legally required to provide their workers with personal protective equipment (PPE) to minimize exposure or contact with...
2.2K
PPE Use in Healthcare Settings I: Donning
1.3K
Donning PPE must be completed before contact with the patient. This process protects from infectious agents. The sequence and action included in each donning are critical, and the steps must be systematic to avoid exposure to pathogens. The institutional policy also needs to be followed while donning PPE. The pre-donning preparations are gathering equipment, inspecting the PPE equipment for tears, holes, or damage, removing jewelry, removing any garments below the elbows, and tying the hair...
1.3K
Personal Protective Equipment
1.9K
Personal protective equipment (PPE) is unique clothing or equipment worn by an employee to minimize or prevent exposure to infectious agents. PPE creates a barrier between the employee and the infectious materials. PPE must be readily available in the patient care area. PPE includes gloves, gowns and aprons, masks and respirators, goggles, face shields, shoes, and headcovers:
1.9K
Hand hygiene
4.2K
Asepsis is the practice of preventing or breaking the chain of infection. The nurse employs aseptic techniques to prevent the spread of microorganisms and reduce the risk of diseases. Hand hygiene is the cornerstone of aseptic techniques and is classified into medical and surgical asepsis. Medical asepsis includes hand hygiene and the use of gloves. Surgical asepsis, or the sterile technique, refers to practices that render and keep objects and areas free of microorganisms.
Hand washing...
Hand washing...
4.2K
Healthcare Associated Infections II: Preventive Measures
2.8K
Essential infection prevention measures are based on the knowledge of the infection chain, the modes of transmission in healthcare settings, and the use of the best practices in all healthcare settings. Compulsory public reporting of healthcare-associated infection rates is needed to allow individuals and the community to make informed choices regarding selecting a healthcare facility.
The best practices for preventing healthcare-associated infections include hand hygiene, patient risk...
The best practices for preventing healthcare-associated infections include hand hygiene, patient risk...
2.8K


