Mastering Equipment Hold Time Controls with Electronic Logbooks

In pharmaceutical manufacturing, every process and step must be precise, particularly when handling and cleaning manufacturing equipment. Clean hold time (CHT) and dirty hold time (DHT) are critical aspects of controlling equipment usage without risking contamination. Mismanagement of these hold times can result in regulatory noncompliance, jeopardize patient safety, and significantly impact production efficiency.

As pharmaceutical manufacturers continue to embrace digital transformation, leveraging tools like ValGenesis e-Logbook for automated hold time management has become essential for mastering these complex processes.

Understanding Clean Hold Time and Dirty Hold Time

Clean hold time refers to the period during which cleaned equipment is considered clean and valid for use in product processing or storage. Based on CHT, the manufacturing site can provide a high-level of assurance that the equipment, under controlled conditions and within a predefined time range, does not risk contaminating the product.

Dirty hold time refers to the validated duration equipment can remain dirty after use in a process. Cleaning soiled equipment with a validated cleaning process is a mandatory step before using it in product processing or storage. Extending beyond the acceptable DHT can lead to residue hardening, increased contamination risks, and microbial growth, making subsequent cleaning more difficult and potentially affecting product safety and integrity. 

Both CHTs and DHTs are validated as part of the equipment and cleaning qualification process. Pharmaceutical companies must adhere to the established time limits in their standard operating procedures (SOPs). Effectively managing these hold times is vital for several reasons:

1. Patient Safety: Improper cleaning can lead to contamination, cross-contamination, or compromised sterility, potentially affecting patient health and safety.
    
2. Manufacturing Efficiency: A lack of control over CHTs and DHTs can lead to unplanned downtime, reduced productivity, and increased cleaning cycles, leading to bottlenecks in the manufacturing process.
    
3. Financial Impact: Noncompliance with CHT and DHT limits can result in batch failures, product recalls, regulatory fines, and additional operational costs related to cleaning validation, product losses, and equipment downtime.

Despite their importance, many pharmaceutical manufacturers struggle to track and enforce hold times, often relying on manual methods that are prone to human error, leading to inconsistencies and risks in manufacturing processes.

Challenges with Hold Times

• Tracking Errors: When CHTs and DHTs are recorded manually, teams can easily overlook time-sensitive tasks, especially in a high-pressure manufacturing environment. Delays or inaccuracies in cleaning logs can result in contaminated equipment being used, putting product integrity at risk.
   
• Complex Scheduling: Determining the correct time to initiate a cleaning or usage process based on varying hold times can be difficult when done manually. The process becomes more complicated when different products require different hold times.
   
• Compliance Risks: Failing to meet hold time requirements can lead to noncompliance with regulatory standards like FDA’s 21 CFR 211.67. This can result in costly 483 observations, product recalls, or regulatory penalties.
   
• Production Inefficiencies: Without automated tracking, manufacturers can either clean too soon, wasting resources, or too late, delaying production and causing unnecessary downtime.

In light of these challenges, many pharmaceutical companies are adopting digital solutions like ValGenesis e-Logbook to simplify and automate hold time management.

How ValGenesis e-Logbook Simplifies Equipment Hold Time Management

ValGenesis e-Logbook addresses the challenges of tracking CHTs and DHTs directly. Through automated business rules, it ensures that cleaning, maintenance, and equipment usage activities adhere to validated hold times, eliminating the risk of manual errors and ensuring compliance.  

Here’s how it works: 

ValGenesis e-Logbook allows users to create customized usage and cleaning log forms associated with specific equipment entities and drug products. Systematic business rules can then be created that utilize validated hold times for the equipment or Process Equipment Train (PET) that can trigger appropriate tasks and enforce technical controls.

Create hold time business rules for associated drug and equipment. 

For example, when using the V cone Blender from the equipment train shown in the screenshot above, you would complete the usage log form. This log counts as one recorded instance. The equipment can be used twice (per the hold time business rule) before required cleaning. After two recorded uses, ValGenesis e-Logbook automatically triggers the start of the DHT.

Once DHT begins, the system recognizes that after two hours, the cleaning task must be completed, and the cleaning log must be captured. If cleaning is not performed within that timeframe, the system marks the equipment as unavailable until cleaning occurs.

After logging the cleaning task, CHT begins. According to standard operating procedure, the equipment is considered clean and ready for use for the next three days. If the equipment is not used within this period, another cleaning is necessary before subsequent use. This automated scheduling and logging of CHT and DHT ensures that the equipment remains compliant without the need for manual intervention or tracking.

Key Benefits of ValGenesis e-Logbook for Hold Time Management

1. Automated Task Scheduling: ValGenesis e-Logbook automates the scheduling of usage, cleaning, and inspection tasks based on your SOPs and validated hold times, eliminating the need for manual tracking. This ensures that no time-sensitive tasks are missed or delayed, optimizing production flow.
   
   
2. Enforced Business Rules: By embedding business rules into log forms, the system enforces proper usage and cleaning schedules. For example, if the equipment is due for cleaning after two uses or when the DHT reaches its limit, the system prevents further use until the required cleaning is performed and logged, reducing the risk of noncompliance.
   
   
3. Improved Compliance: ValGenesis e-Logbook automatically captures electronic timestamps, ensuring that all log entries are fully traceable and comply with 21 CFR Part 11 and Annex 11 regulations. This traceability is critical for ensuring compliance during regulatory inspections.
   
   
4. Operational Efficiency: With this tool, you can minimize downtime by ensuring that equipment is always ready for use. Automated reminders for cleaning and usage logs prevent over-cleaning or under-cleaning, which can waste time and resources and delay production.
   
   
5. Customizable Forms and SOP Integration: The platform allows you to design and customize log forms to align with your specific SOPs. Whether for equipment usage or cleaning, you can create tailored forms that reflect your business rules, ensuring all relevant data is captured accurately and consistently.
   
   
6. Offline Capabilities: The ValGenesis Mobile Application enables operators to capture log data in offline environments, which is particularly useful in facilities with limited network availability. Once the connection is restored, the data syncs seamlessly, eliminating the need for manual data entry and reducing the risk of transcription errors.
   
   

The Impact of Automated Hold Time Management

Mastering hold time controls is essential for maintaining operational efficiency, ensuring product safety, and complying with regulatory standards in pharmaceutical manufacturing. Clean hold time and dirty hold time are critical parameters that, if managed poorly, can lead to contamination, production delays, and regulatory penalties.

ValGenesis e-Logbook offers an automated solution to streamline the tracking and enforcement of hold times. This enables businesses to optimize their manufacturing processes, ensure compliance, and improve overall operational efficiency. By digitizing log entries, enforcing business rules, and integrating seamlessly with your SOPs, ValGenesis e-Logbook empowers you to stay ahead of the curve and avoid the pitfalls of manual hold time management.

To explore ValGenesis e-Logbook further, we invite you to watch our webinar, Beyond Binders: Instant Accessibility to All Your Logbook Data. Gain actionable insights and enhance your understanding of logbook management.