— Services
Services & Specialties
End-to-end engineering consulting for sterile pharmaceutical production —
from initial facility concept through qualification, commissioning, and ongoing operational support.
Proper design assures functional needs and regulatory requirements. Essential for efficient operation and obtaining regulatory approvals smoothly. Covers layout, material/operator/waste flows, pressure cascades, airflows, and clean room classification.
Covering the entire field of engineering procurement — from writing specifications and User Requirement Specifications, comparing suppliers, performance of acceptance tests (FAT, SAT), to obtaining the best selection of equipment at the lowest costs.
Detailed planning of production processes serving as a basis for production worksheets and computerized control systems. Proper scale-up requires thorough understanding of system components and the physical parameters that characterize them.
Sterile production includes complex technologies such as bulk sterilization, homogenization, and particle size reduction. Deep knowledge of these technologies and equipment provides significant advantage in assimilation time and implementation accuracy.
Targeted training for engineering, operations, and quality teams supporting sterile manufacturing, including practical guidance and knowledge transfer.
Design and validation support for moist and dry heat sterilization processes, including cycle development, technical review, and process assurance.
Full CQV services: IQ/OQ/PQ management, protocol writing, clean room and equipment qualification, SOPs, quality policies, and regulatory compliance including 21 CFR Part 11 and Annex 1.
When a sterile production line fails, when a process is unstable, when equipment integration does not perform as expected — rapid diagnostic response to identify root causes and deliver practical, implementable solutions.
The updated Annex 1 is the most significant regulatory change in decades. 10AR provides deep expertise in CCS development, barrier technology guidance, PUPSIT implementation, and comprehensive gap analysis services.
Vials, syringes, ampoules — washing, depyrogenation, filling, stoppering, and crimping.
Support from purchasing to testing for automatic visual inspection systems in sterile production lines.
