Compliance, Risk and Cost of Ownership in Critical Pharmaceutical Facilities

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December 8, 2010 —

Introduction: Modalities for Monitoring Critical Environments

Figure 1. Risk Factors — Continuous Monitoring Modalities. This chart provides general guidelines only to risks associated with meeting GMP requirements. Source: Veriteq, a Vaisala Company. Click here for hi-res version (opens new tab/window).
Continuous Monitoring Modalities

Figure 2. Costs of Ownership Factors — Continuous Monitoring Modalities. The following chart provides general guidelines only for some of the more salient factors affecting costs of ownership related to the six monitoring options. Varying plant sizes and scale of operations affect the impacts of various cost factors. Source: Veriteq, a Vaisala Company. Click here for hi-res version (opens new tab/window).
Cost of Ownership Factors

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Paper-Based Chart Recorders

Data Loggers

Wired Networks — With and Without PoE Capabilities

  • Saves the cost of running additional AC power, which usually requires a licensed electrician, aided by the low cost of network switches with built-in PoE power capability;
  • Provides greater flexibility to locate devices around the plant because they can be installed wherever a LAN cable can be run;
  • Increases data communication protection from power outage because the server's UPS provides backup to PoE connected devices;
  • Uses less energy and can be managed from a central location; and most importantly,
  • Protects critical data through the outage period.

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Wireless Networks — WiFi and Mesh

Figure 3. Topology of WiFi and Mesh Wireless Networks. WiFi devices connect directly to the company network and use WiFi access points to transmit data to a central host (server). Mesh devices connect to a gateway that can either host the data or forward to a central server. Source: Veriteq, a Vaisala Company.
Topology of WiFi and Mesh Wireless Networks

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Data Redundancy

Data Security

Conclusion: Quantify Risk and Cost

  • Can you afford to handle the expense of downtime? This can be in the form of missing data, equipment failure or human error.
  • For an unplanned production stoppage, how long will it impact other research, production or shipments?
  • What is the financial impact of losing product or research specimens?
  • Can you define downtime cost either by time, lost production, blemish to reputation or other stakeholder pain?
  • Can you identify single points of failure and ways to reduce them?
  • Does it cost more to recover from equipment failure, product loss, internal and external reviews and other unplanned interruptions than it would cost to invest in continuous operation?


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