Smoke Studies
Smoke Study for aseptic safety
We make airflow visible – for the verification of directed airflow, the optimization and qualification of your cleanroom, RABS or isolator system in accordance with Annex 1, ISO 14644, VDI 2083, FDA, PMDA, PDA.
We perform the qualification of the aseptic core zone of your facility with the aid of smoke studies for isolators, RABS and cleanrooms (at rest and in operation, including all necessary interventions). We take care of the entire process for our customers: from planning and on-site implementation to the creation of regulatory-compliant documentation.
In addition, we represent the topic of flow visualization for our customers in inspections and commit the regulatory communication on your behalf.
Smoke studies provide quality control and assurance and ensures safety and purity in the aseptic core zone of your facilities in compliance with regulations.
Services
- Organization and implementation of project meetings
- Planning and conducting on-site inspections
- Preparation of project documentation including data collection, risk analysis, script, plan, and report
- Conducting filter integrity tests
- Air velocity mapping in accordance with Annex 1 and ISO
- Use of various tracer injection methods (use of water- or oil-based tracers)
- Life cycle of a smoke study with:
- New construction of a plant/ room and performance of qualification
- Conversion measures on existing plants
- Checking the currency of existing material
- Review
- Review
- Compilation and evaluation of video material
- Consulting regarding existing smoke studies
Your added value
- Verification and understanding of flow characteristics in the aseptic core zone
- Ensuring product quality by identifying problem areas
- Optimization of processes and plant layout based on the results
- Provision of supporting and conclusive information on flow in the aseptic core zone
- Reduction of risks and costs through preventive measures of smoke studies
- Improving the visuality of flow simulation
- Use of recorings of training purposes and internal customer communication
Area of application
- New cleanroom constuction
- Conversion of process expansion of isolators or RABS
- Air locks
- Training videos
- Audits
- Recertification
- Continuous monitoring
Norms and standards
- EU GMP Annex 1
- ISO 14644
- VDI 2083
- PMDA – Guidance on Aseptic Processing
- FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing
- PDA Standards
REFERENCES– Projects already implemented
Isolator system
Initial qualification
- Filling line for prefilled syringes with 2 isolator segments and 3 laminar flow (LAF) units
- Filling line for multi-use inserts with isolator
- Filling line for vials and syringes for clinical samples
Requalification
- Isolator after adjustment of the pressure cascade
- Filling line for vials with 3 lyophilizers, after conversion of fans in the isolator
- Filling line for vials after adjustment of interventions
- Filling line for bottles for routine requalification
RABS systeme
Initial qualification
- RABS system for unpacking outer packaging
- RABS system for crimping
- RABS system for material feeding
Requalification
- Filling line with RABS system using single-use filling quipment
- RABS system after conversion, including loading trolley
Other visualizations
Initial qualification
- Automated assay systems
- Implementation visualization for FAT and SAT
- Food filling
Requalification
- Clean rooms
Air locks
Overflow of different cleanroom classes - Air locks
- Overflow of different cleanroom classes
LEARN MORE
Smoke studies in the aseptic core zone
This article outlines the visualization requirements and practical implementation for preparing and performing the validation of laminar air flow in the aseptic core zone using risk- based approach.
Mr. Clemens Herold
Is your contact person for the area of FLOW VISUALIZATION/ SMOKE STUDIES
E-Mail: smokestudy@pp-technology.de