Automation

Manufacturing Automation uses technology to ensure processes are repeatable, systems are reliable, and overall productivity is optimized.  With the Industry 4.0 revolution in full swing, our clients are moving towards more robust, agile manufacturing capabilities to keep up with ever-changing demands.

Packaging lines that were once product-specific are now required to handle multiple formats with quick change-over times.  Smart Manufacturing uses certain metrics such as OEE (Overall Equipment Effectiveness) and Utilization to enable better decision making at the plant level.

With the convenience of manufacturing automation comes the compliance expectation, to ensure systems used for GMP processes preserve the integrity of the digital data.

SAGE understands how to implement compliant, cost-effective and innovation automation solutions that meet GAMP5 guidelines and 21 CFR Part 11 regulations.  SAGE’s expertise comes from our industry knowledge and technical experience in the following key areas: Packaging, Processes, Inspections and Data Integrity

 

Packaging

SAGE has completed new and existing (retrofit) automated equipment projects for many packaging formats, including bottles, blisters, tubes, and sachets.  We develop equipment trains on Primary and Secondary packaging lines that reflect the capacity needed to meet our client’s increasing volume forecasts.

Key Projects

Equipment & Facility Engineering

Equipment

Reconfiguration of a small volume Nasal Packaging line, including crimp inspection station, PDC neckbander and shrink tunnel

Automation

Equipment engineering and IT integration lead for an automated OEE system installed on multiple solid-dose packaging lines, including installation and commissioning

 

Processes

SAGE has ability to learn client specific processes quickly and work with equipment vendors and OEMs to integrate automated solutions that meet quality, functional and technical requirements.  Converting a manual process to an automated one requires an in-depth knowledge of equipment limitations, risk-based methodology for testing critical functions, and integration with upstream and downstream processes.

Key Projects

Equipment & Facility Engineering

Facilities

Design and calculations for Control System enclosure purging system to reduce explosive atmosphere

Compliance & Validation

Equipment

IQ/OQ for a Clean in Place (CIP) system for a large-scale batch process

Project Management

Equipment

Developed an automated solution for a medical test cartridge assembly process, including process design, specification development, and vendor management

 

Inspections

A machine vision system can eliminate the need for tedious manual inspection of products.  However, automated detection performance should be closely aligned with that of manual operators in order to successfully validate the system.  The primary benefits of switching to an automated inspection system are repeatability and speed.  Also, defects found by the machine can be evaluated and upstream processes can be corrected to eliminate rework and waste.

SAGE has successfully designed, installed, and qualified Vision Systems from individual devices all the way to integrated enterprise systems to inspect products for foreign particulate, container integrity, lot ID and expiry date identification, cosmetic defects, and correct fill level / count.

Key Projects

Equipment & Facility Engineering

Equipment

Clinical batch project for topical medication, including new mixing tanks, in-line powder disperser, and tube filler

Facilities

Large-scale project for Topical Aerosol Foam products with flammable liquid, including dispensing of OHC Category 4 and 5 compounds within a containment isolator

Process

Design, installation and validation of automated inspection machines for injectable drugs

Compliance & Validation

Equipment

Vision system for automated inspection of tubes to verify quality attributes, including contamination, tube diameter, crimp seal, and Lot/Exp presence

Project Management

Equipment

Large-scale project for a topical pain medication scale-up, including infrastructure, manufacturing and packaging readiness to develop capacity of 30 million tubes annually

 

Data Integrity

With the growing amount of data being used to measure metrics, evaluate support and so forth, the importance of its integrity is brought to the forefront. Often the subject of audits, computerized systems must be validated and its data authenticated, time stamped, and traceable. The transition from massive amounts of paperwork to digital systems brings undeniable advancement and value to companies. It also brings many rules and policies to ensure the data is contemporaneous and authentic.

SAGE has successfully designed, audited, and qualified computerized systems to be compliant as per industry regulations.

Key Projects

Compliance & Validation

Process

Reviewed, tested and confirmed software design standards compliance to GAMP5 methodology for Track and Trace software solutions, from Line Equipment to ERP system

Equipment

Change control managed and re-qualified multiple upgraded production equipment to be compliant with updated data integrity regulations

Process

Implemented a new Artwork Management System, including GxP Applicability Assessment, Supplier Audit, User Requirements Specification and Performance Qualification (PQ)

Project Management

Process

Design, configuration and testing of user access levels with integration to client’s LDAP server