Clean room compatible automation for pharmaceutical packaging and medical device assembly with full validation support.
Clean room classification requirements (ISO 5-8)
Serialization and track-and-trace compliance
Validation and IQ/OQ documentation
GMP compliance and audit readiness
Batch records and electronic documentation
ISO Class 5 compatible robots with smooth surfaces, minimal particle generation, and validated cleaning procedures.
Vision systems and data management for 2D barcode printing, verification, and aggregation compliance.
Complete IQ/OQ/PQ documentation, FAT/SAT protocols, and validation assistance for regulatory compliance.
$780K annual savings, passed FDA audit
"The clean room cell met all our validation requirements and the serialization integration was seamless. FDA inspectors were impressed with our documentation."
Get a free consultation and custom automation proposal for your facility.