WHAT IS DISINFECTION METHOD VALIDATION?
What has to be tested and validated?
VALIDATION AND REPRODUCIBILITY
– Of the cleaning
– Of the disinfection
– Of the decontamination in situ.
QUALIFICATION OF THE DISINFECTANTS AND OTHER ANTIMICROBIAL CHEMICAL AGENTS
– Choice of products
– Worst case efficacy tests
– Measurement of residues
– Product compatibility / interference
MONITORING OF THE ENVIRONMENT
– before and after start-up (of the unit, of the new area) or after shut-down
– before and after cleaning and disinfection during routine operation
– Maintenance of validated state.
COMPREHENSIVE SUPPORT FOR CLEANING VALIDATION
HeX, your partner in contamination control, provides support to the whole cleaning validation process. From risk assessment, through the validation plan, strain identification, conduct of qualification tests, etc., to application of the data.
- Support in drawing up URS, Risk Assessment, Strain identification strategy, Validation plan, IOQ, PQ
- Conduct of IOQ, PQ qualification tests :
– Microbial ecology
– Selection of strains
– Worst case surface tests
– Measurement of residues / product risk
– Compatibility of products
- Support with sampling, training, transport, analysis
- Reading and analysis of results using LYRA® software, data acquisition and monitoring system.
is a procedure enabling proof to be provided that the processes for cleaning manufacturing equipment prevent the contamination of products. Cleaning validation must be correctly documented in order to demonstrate current good manufacturing practice (GMP) for finished pharmaceutical products.
PRINCIPLE of cleaning validation
It is essential to define precisely the threshold acceptance criteria in cleaning validation in order to establish the results of the study. In order to enable a better assessment of whether cleaning methods are effective or not, the acceptance criteria for validation of the cleaning can generally be classified in terms of three test parameters:
Physical criterion : a visual inspection of the equipment must show the absence of any particles or residues.
Chemical criterion : not more than 10 ppm (parts per million) of a product may be detected in another product and/or not more than 0.1% of the normal therapeutic dose of a product may be appear in the maximum daily dose of another product.
Microbial criterion : according to the levels determined :
of disinfectants and other antimicrobial chemical agents
The standard European approach for the validation of disinfectants comprises :
– a basic suspension test,
– a quantification suspension test (with low and high levels of organic matter added to act as interfering substances) and
– a simulated usage surface test in two parts.
Thus, this standard European approach for the validation of disinfectants is divided into three phases :
1. Phase 1 → Basic suspension tests
2. Phase 2 in order to simulate practical use: Bactericide and fungicide (sporicide and virucide).
Part 1 : Tests in suspension
Part 2 : Surface tests
3. Phase 3 → In-situ studies
STANDARD FOCUS :
ANNEX 1 OF THE GMP
Microbiological monitoring is necessary outside manufacturing operations :for example after :
– The validation of systems, cleaning and sanitisation
– The validation of systems, cleaning and disinfection
MONITORING and MAINTENANCE of the validated state
Microbiological monitoring enables maintenance of the validated state and avoidance of non-conformities. The frequency of tests and the sampling points defined in the validation plan and protocols are the subject of sampling and analyses.
HeX offers you a turnkey solution :
1/ Documentation support
3/ Supply of equipment and consumables
4/HeX transport, controlled and monitored conditions guarantee and secure the preservation of your samples.
5/ Analyses guaranteed and secured by our GMP recognised QC laboratory
DATA PROCESSING AND ANALYSIS
HeX Lyra® data entry software is a data acquisition and monitoring system.
It enables digitisation of the entire process: Documentation, Sampling programme, Transport, Sample analysis as well as staff training, work planning, etc.
The objective: to identify and anticipate any deviations in order to maintain the validated state and avoid non-conformities.
Based on the threshold parameters in your validation plans and risk assessments, you will receive notifications in the event of deviations.
The advantages of Lyra® thresholds and alarms configured according to your criteria and context, no untimely or unnecessary alerts
THE HeX LAB GUARANTEES
ISO 17025 Compliant
Flexibility, listening to customers
Data entry system 21CFR