Automated Systems, Inc.

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Selected Projects

Automated Systems Inc. has been providing the pharmaceutical industry with controls and validation support for eighteen (18) years. From this long history of service to the industry, ASI has selected the following projects to demonstrate our proven track record of success with process / equipment validation.

Startup and Validation of 60,000 square foot Diagnostics Facility

Startup and Validation of 60,000 square foot Diagnostics Facility ASI was contracted by a top diagnostics manufacturer to start up and validate a new manufacturing facility. ASI was responsible for IQ/OQ/PQ generation and execution for equipment and utilities within the facility. Systems included eight (8) fill/label lines, purified water still and distribution system, CA system, chiller, autoclaves, washers, and coolers. This was a time critical, high visibility project. ASI achieved all deliverables and brought the project in on schedule

Qualification and Validation of Grass Roots Diagnostic Manufacturing Facility

ASI provided services to qualify and validate equipment, utilities, facilities, HVAC, and computer systems for an 89,000 sqft facility containing manufacturing areas, support areas, utility / building services areas, receiving / shipping docks, warehouse, cafeteria and parking areas and support offices. All documentation was to comply with the following regulations

EU Directive 91/356/EEC

BS ENISO 9001

United States Code of Federal Regulations 21CFR Section 820

The process involved printing of different inks on to a PVC card. These inks were applied using screen printing technology, where the ink is held within the stencil and transferred onto the substrate with the passing of a squeegee blade over the stencil surface. The test strips were built up by applying multiple layers of ink, two layers of mesh and a tape layer to produce the finished product. This process required extremely tight temperature and humidity control. This facility passed it’s FDA pre-approval inspection with no observations.

Lyophilizer Control System Development

ASI was contracted by a major parenterals manufacturer to develop, install and validate a control system for multiple lyophilizers. The control system consisted of a Modicon 584 PLC and an Intellution iFIX HMI at each lyophilizer which were also controlled and monitored from a central control room having three (3) supervisory nodes. The system included central recipe and alarm management and comprehensive reporting. ASI performed the design, installation commissioning and startup of the control system. The entire system where applicable, including the data archiving was designed and validated to be 21 CFR Part 11 compliant. Project was a phased, multiyear commitment for up to three ASI controls engineers.

Kilo Lab Control System Development

ASI was contracted to provide a complete control system for a Kilo Lab operation consisting of multiple reactors and their support systems. The controls functionality was performed by an Allen Bradley ControlLogix PLC with RSView SE HMI having multiple terminals. ASI developed the control algorithm, designed all screens and interfaced the system with an existing plant network. ASI started up and debugged the system and also prepared and executed IQ/OQ/PQ documents for all manufacturing and support facilities. WFI Water System Controls Development.

ASI was responsible for providing Instrumentation and Controls Engineering services to help design , commission and validate a Water for Injection System. Developed code for multiple ControlLogix PLCs and RSView ME HMI panels.

Clean Zone Project

ASI provided project scope development and project management services for an eighteen (18) month project to upgrade, modify, re-commission and revalidate the HVAC and Building Automation System for the fifteen (15) air handling units serving the manufacturing clean zone. Project scope included the evaluation of the design and performance of existing equipment against the revised Quality Standards for clean rooms, development of a revised design to meet said Quality Standards and management of contractors to upgrade, test and commission, document and qualify the facility. The resultant end product included new accurate single line HVAC schematic diagrams and system commissioning reports which have enabled the plant to be maintained and operated more efficiently.

Steris Sterilizer Controls Upgrade, Commissioning & Validation

ASI was contracted by a major parenterals manufacturer to develop, design, install, commission and qualify a new controls package for a Steris Autoclave. The project included replacement of the sterilizer’s PLC, and HMI. Programming changes and full commissioning and qualification package were also included.

Autoclave GAMP 4 Computer Validation

ASI provided validation and project management services to complete a GAMP 4 revalidation of five (5) GMP autoclaves for a Fortune 1000 Hospital Products manufacturer. All documents were delivered on time and executed with minimal deviations.

R&D Autoclave Qualification

ASI was contracted to supply full qualification services for new Allpax and Getinge autoclaves. ASI prepared and executed a project validation plan, design specification, functional requirements specification, risk assessment, regression analysis, IQ, OQ, and summary report for the R&D division of a Fortune 1000 Hospital Products manufacturer.

Validation Master Planning for Fortune 50 Pharmaceutical Manufacturer

ASI was contracted by SPD’s corporate quality function to create Validation Master Plants for each of SPD’s 40 plants, laboratories, and corporate utility groups. ASI drafted validation master plans to conform to the new corporate standard for Bulk Chemical, Fermentation, Finishing, and Biological Manufacturing Plants Mainland and Puerto Rican sites. Services included drafting, verifying, revising and obtaining approval for all required VMPs.

Compliance Assessment

A Fortune 500 OTC manufacturer commissioned Automated Systems Incorporated (ASI) to perform an assessment of its two North American manufacturing sites. The main objective of this activity was to assess the current validation approach in terms of both principle and implementation and to recommend modifications to the current approach that would help the client achieve its FDA obligations in an efficient and timely manner.

ASI’s recommendations to more quickly and efficiently execute the project were to focus on high priority items using a risked based approach to validation activities, and to employ bracketing techniques in process and cleaning validation. These steps were to provide substantial time savings over the current strategy.

Warning Letter Response

ASI was retained by a medical device company to provide guidance for Warning Letter response. ASI personnel consulted with the client to put in place a strategy for responding to the warning letter. This guidance included a detailed approach for responding to each point of the warning letter and also what physical attachments to provide along with the response. Final review of the response was also performed by ASI.

Mock Audit

ASI was hired to perform a mock FDA pre-approval inspection to help a medical device company prepare for an upcoming PAI. Inspected all aspects of the plants quality system and found issues relating to the following subparts of the QSR

B. Sub-Part I - Nonconforming Product 820.90(a) & 820.150 Handling

C. Sub-Part D – Document Control 820.40(a)

D. Sub-part G – Production and Process Controls 820.72(a)(b)(2)

Issues were classified as minor, major, or critical and recommendations were given for there remediation. The plant subsequently passed its pre-approval inspection.