The pharmaceutical industry demands the strictest regulatory compliance. The Flyability ELIOS 3 inspects bioreactors, fermenter tanks and cleanroom areas without human entry – GMP-compatible, contamination-free and fully documented. Since 2017.
The pharmaceutical industry is subject to one of the strictest regulatory frameworks in the world. GMP (Good Manufacturing Practice) per EU GMP Guidelines (Annex 1 through 20), FDA 21 CFR Part 211 and ICH Q7 mandates that all processes, rooms and equipment that come into contact with pharmaceutical products or influence their quality must be controlled, documented and – where required – validated.
A drone deployment in a pharmaceutical facility is therefore not a standard industrial mission. It must meet the following requirements:
Kopterflug inspects the following pharmaceutical asset types with the ELIOS 3:
Whether and in which cleanroom area a drone can be deployed depends on the cleanroom class (ISO 14644-1, EU GMP Annex 1) and the operational state (at rest vs. in operation):
Class A / ISO 5 (core zone): Drone deployment fundamentally only in at-rest state and only in coordination with quality management. Cleaning and disinfection of the drone per manufacturer protocol and after QA approval.
Class B / ISO 7 and C / ISO 8: Drone deployment possible after emptying and cleaning of the area. Particle monitoring before and after deployment recommended. Deployment is noted in the batch record or area logbook.
Class D / ISO 8 and non-classified rooms: Drone deployment with standard cleaning protocol for industrial environments. Proximity to GMP areas must be documented.
Emptied GMP vessels (tanks, bioreactors): After complete emptying, CIP completion and before refilling, the drone is the most efficient tool for internal condition assessment. No person needs to enter the vessel – this significantly reduces contamination risk from human presence.
The workflow for a GMP-compliant drone deployment in a pharmaceutical facility differs from standard industrial missions through additional documentation and coordination steps:
Yes – when properly integrated into the quality management system. The ELIOS 3 deployment follows a defined protocol: cleaning with approved agents, documented foreign body check, deployment only in emptied and cleaned vessels, and a complete audit-trail-capable report. The deployment is logged in the equipment logbook and can be referenced in validation documentation.
Depends on the cleanroom class. In Class A (ISO 5), only in at-rest state with QA approval. Classes B/C (ISO 7/8): after cleaning, with particle monitoring before and after. Class D and non-classified areas: with standard industrial cleaning protocol. In all cases, the deployment is coordinated with quality management and documented in the area logbook.
Multiple measures: the drone is cleaned (and disinfected if required) before deployment using a defined protocol. Only emptied and cleaned vessels are inspected. Sensitive areas are covered if needed. A systematic completeness check ensures no parts are loose. After the flight, the same check is repeated. All measures are documented.
The drone deployment can be integrated into the maintenance documentation of qualified systems. Evidence is provided that the drone does not affect the qualification status of the equipment. The inspection report, cleaning protocol and flight log form part of the documentation chain and are compatible with 21 CFR Part 11 requirements.
Typical findings include: weld seam quality issues, surface roughness changes (Ra value), coating integrity problems, condition of agitators, sensors and internal fittings, dead-space areas with insufficient CIP effectiveness, and corrosion at connections and nozzles. All findings are documented in 4K with precise position reference.
Key frameworks include: EU GMP Guidelines (particularly Annex 1 for sterile manufacturing, Annex 15 for qualification and validation), FDA 21 CFR Part 211 (cGMP for finished pharmaceuticals), ICH Q7 (GMP for APIs), and ISO 14644-1 (cleanroom classification). The drone deployment is adapted to the specific regulatory requirements of each facility.
In many cases, yes. A person in full cleanroom gowning is a significant particle source. The drone – properly cleaned and without human presence inside the vessel – introduces fewer uncontrolled particles. This is particularly relevant for product-contact surfaces in bioreactors and WFI (Water for Injection) tanks.
You receive: 4K video footage, high-resolution finding photographs, an inspection report with classified findings and action recommendations, the cleaning protocol, the foreign body check protocol and the flight log. All data is delivered in formats compatible with pharmaceutical document management systems (DMS) and GMP archiving requirements.
Do you need GMP-compliant drone inspection for your pharmaceutical facility? Describe your assets and GMP requirements – we will develop an inspection concept that fully meets your quality assurance standards.