NOVA-CLEANING VALIDATION

NOVA-CLEANING VALIDATION
From a regulatory and industry perspective, clean validation is considered crucial for patient safety and product quality as it ensures effective control of product contamination. The method of manually managing the cleaning process on pharmaceutical production lines is time-consuming, prone to human errors, and may pose regulatory risks to pharmaceutical factories. Nova Cleaning Validation is a revolutionary software module that accelerates the cleaning validation process, improves result accuracy, and reduces non-compliance risks.

NOVA-CLEANING VALIDATION

Intelligent risk assessment system, locking in the worst-case scenario. This system can define multiple risk factors, such as dosage, toxicity, cleanability, solubility, etc. These factors can be set individually or in combination, giving users comprehensive evaluation control. The system identifies and displays the worst-case scenario for all validation groups, allowing users to focus on the biggest risk factors affecting product quality. Once any validation group attribute changes, the worst-case assessment will automatically start.

Automated MAC calculation. The system calculates residual limits for AP1, cleaning agents, and microbiological testing for all sampling points. Hundreds of MAC formulas can be executed in seconds (not hours). When calculating, all possible combinations of product A and product B on the affected device chain, as well as all validation groups, were considered, and the MAC value was highlighted to enable users to quickly and easily review the calculation results.

The dedicated risk control function integrates the impacts of multiple changes into one risk snapshot, displaying any changes in factors that may affect the validation status of the cleaning process and their consequences. These factors include replacing equipment, introducing new products, modifying batch sizes, or other matters related to equipment combinations and products in the equipment chain and validation group.

降低成本

Compared with manual processes, implementing an automated cleaning validation system can significantly save time and resources. By automating worst-case scenario assessment and thousands of MAC calculations, tasks that originally required hours can be completed in minutes.

Reduce errors

Data input errors or calculation errors can increase the likelihood of contaminated products, potentially resulting in millions of dollars in losses, while Nova Clean Validation is a paperless system that reduces human errors.

data integrity

Nova Clean Validation complies with 21 CFR Part 11 regulations, providing data security and compliance, as well as automated system assessment and computation functions. Regulatory auditors will be able to clearly see whether the process is in a controlled state.

transparency

The electronic management and approval of master data ensure efficient sharing of information. All data related to equipment, analysis methods, and validation groups are available to all stakeholders, providing transparent information for each functional group.

Simplify management

Create association validation groups for single or multiple device chains, allowing users to easily define and manage product and device combinations.

System Definition Protocol

Based on the defined sampling points, analysis methods, and MAC limits, the system automatically generates a sampling plan for the validation group. Users can arrange verification or monitoring events according to approved protocols.

Data and Analysis

The comprehensive reporting function enables users to retrieve any data with just a few clicks and provides a variety of in-depth standard reports. Trend and statistical analysis include ability indices, regression analysis, scatter plots, and other types of charts.

Implement compliance and prevent regulatory issues

Nowa Clean Validation significantly improves product integrity by managing changes and assessing risks related to cross contamination and product impurities in dynamic production environments. Method APIS、 The system automatically evaluates changes that occur in products, equipment, and product family groups to ensure product integrity and regulatory compliance.

Nova Clean validation complies with the requirements of 21CFR Part 11l and EU Annex 11. This module adopts a risk-based approach, and its design is based on PDA technology reports 29 and 49 ISPE MaPP、21 CFR Part 211.67、 Cleaning process validation (7/93) and EU Annex 15.