洁净室污染控制顾问

环境监测风险/差距分析

使用科学且基于风险控制的方法为您的环境定义或检查监测取样点。

• 空气 (单纯粒子, 微生物和粒子)
• 表面
• 灌装机
• 无菌和非无菌生产环境
• 环境微生物负载
• 微生物

环境监测趋势分析

验证你的环境数据是否符合统计控制要求，识别数据趋势，发现并解决问题，以统计的方式定义警戒和行动限。

应用

以科学和风险把控为基础的方法分析生产和监测点，并根据您的流程设置正确的监控取样频率。

• 纯净水(PW)和自来水
• 注射用水(WFI)
• 纯蒸汽
• 压缩气体(空气、氮气、二氧化碳，等等)

Cleaning and Disinfection

Identify the right cleaning and disinfection strategy and plan according your environment, surfaces, and manufacturing processes, providing the rationale for:

• The cleaning and disinfection agents.
• The cleaning techniques.
• The disinfectants’ application, rotation, and frequency according to the different surface typology.

Gowning processes

Identify the gaps in the gowning procedure in use, set the personnel qualification and monitoring points with a scientific and risk-based evaluation of the gowning process and the exposure of your clothes during the manufacturing.

Process Risk Assessment

Increase the quality and the sterility assurance of your manufacturing processes using the most innovative and strong risk analysis techniques, preventing sterility deviations and microbiological OOSs. (Out of Specifications)

• Filling processes
• Upstream and Downstream manufacturing processes
• Process scale up
• Critical Control Points definition
• Definition of the microbiological control on the primary packaging for no-sterile products

Aseptic Process Simulation

Design the “media fill” simulation for your filling process or verify the compliance of the simulation you have in place. Assess the critical interventions made during the production and which must be simulated during the Aseptic Process Simulation using a risk-based approach.

New filling line (Quality by Design)

Design your new filling line and process in quality from the beginning using our strong microbiological and sterility assurance support.

• Mock-up inspection
• Environmental monitoring risk assessment for sampling points
  • Air (total particle & microbial)
  • Surfaces
• Process optimization
• Project Management support (on-field and remote)
• Final drawing approval

Crisis Management

Our microbiologists can help you to handle the deviations and to find the root cause of a contamination outbreak.

• Investigation result review for sterility/microbiological deviation
• Root cause investigation support using risk-based techniques

Audits

We can help you to prepare the regulatory inspection with a mock audit or to define how to increase the quality and the sterility assurance of your manufacturing. Our audits cover:

• Filling processes
• Upstream and downstream processes
• Cleaning and disinfection
• Sampling and monitoring
• Utilities
• Gowning process

Microbiological laboratory

PMS does not leave you alone and support you during the first use and the implementation of its solution. Our team of experts can help you, providing

PharmaIntegrity™

• User Requirement Specification
• Process Mapping
• Performance Qualification protocol and the assistance for the execution
• SOPs

BioCapt® single-use

• Performance Qualification protocol (PQ2) for Standard Application
• Performance Qualification protocol (PQ2) for No-Standard Application
• Support for the review and the interpretation of the qualification results

FacilityPro®

• Coming Soon

Our experts can provide training at your site or organize events and seminaries.Basic training

• Environmental and Personnel Monitoring
• Cleanroom behavior and best practices
• Cleaning and disinfection strategy
• Good Distribution Practices (GDP)
• Microbiological laboratory best practices
• Qualification vs Monitoring

Advanced training

• Aseptic Process Simulation
• Quality Risk Management approach
• Fundamental of Statistics and trend analysis
• The new EU GMP Annex 1

Coaching (one-to-one training)

• • Quality Risk Management
  • Sterility Assurance
    • Manufacturing processes
    • Documentation
    • Corporate procedure and organization
  • Microbiological Laboratory
    • Analytical methods
    • Procedure and organization