Let’s face facts; manual monitoring of cleanroom particulate counts is costly, monotonous and highly error prone. Cleanroom managers are very aware that by far the greatest contamination threats come from individuals entering controlled spaces. Understandably, to reduce the number people accessing these critical environments, many companies are tasking the cleanroom operations staff already working within these spaces with the additional responsibility for manual environmental monitoring (EM). While this approach has obvious benefits, such as lower labor costs and reduced contamination risks, it also introduces significant new data integrity issues.
Human Interactions Invite Data Integrity Violations
Manual particle counting operations take considerable time with many facilities performing at-rest and operational tests multiple times at multiple locations throughout the day. Thousand of records are managed with many human interaction points, all of which create opportunities for critical data to be lost, misunderstood, miss-transcribed, corrupted or otherwise compromised.
Even those organizations that adopt a semi-automated approach to EM can inadvertently create new risks. For example, many modern particle counters support the ability to store sample records to removeable media such as USB memory sticks. While their use is certainly more convenient and efficient than paper clipboard recordkeeping, these devices in themselves present challenges. They are repeatedly brought in and out of the cleanroom and my carry physical as well cyber contamination threats.
The importance of data integrity cannot be overstated with the vast majority of recent FDA issued 483s (Notices of Inspectional Findings) and Warning Letters citing this issue. Not only does data integrity compliance safeguard patient safety, it also protects organizations from the serious financial consequences of FDA's enforcement action such as facility shutdown, product recalls, import and/or distribution bans, delayed or denied drug approvals, substantial remediation costs, and loss of customers due to a damaged reputation.
The Setra CEMS Automated Solution
Addressing these concerns, Setra CEMS software provides a comprehensive, robust automated particle counting solution. Eliminating manual EM workflow steps, CEMS has been developed upon FDA recommended ALCOA+* principles and fully supports 21 CFR Part 11 compliance.
As shown below, continuous or periodic data samples collected from fixed location or portable particle counters and other critical parameter sensors can be locally aggregated over wired or wireless media and securely sent to the highly available and redundant CEMS cloud-based server platform. Unlimited, persistent archives of these records can be generated automatically or on-demand.
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Suitably authorized users can view live or archived data from any browser-capable device from anywhere in the world. Trends can be analyzed, and parameters compared to understand space performance and identify correlations and potential causation between critical parameter excursions and events such as door openings, differential pressure anomalies, shift changes and specific operations taking place within the space. Additionally, alerts and alarms can be sent to preempt and rapidly respond to out of specification conditions.
In conclusion, utilizing Setra CEMS as an automated particle counting solution allows customers to:
- Drastically reduce or eliminate manual workflow steps.
- Optimize data integrity.
- Unburden cleanroom operations staff.
- Use trend analysis to prevent possible contamination events and unplanned downtime.
- Facilitate continuous audit-readiness, providing immediate real-time and historical cleanroom performance records for staff, auditors and customers.
- Fine-tune their cleanroom performance based upon a comprehensive understanding of the space dynamics.
These points, coupled with the fact that unavailability of business-critical assets such as cleanrooms is hugely expensive, lead to the realization of a rapid Return On Investment for such projects.
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