Clients

Aseptic Filling
Upgrade of existing aseptic vial filling and capping equipment in a Class 100 environment.

Emergency Generators
Procure, install and start up of an emergency generator and switch gear system to provide emergency power to the facility during power outages.  Services also included commissioning of equipment.

Syringe Renovation Project
Consists of upgrading piping systems such as nitrogen, vacuum, and ventilation within a formulation area to make them more reliable.

Sterile Filling Room Class 100-Building D
The task consisted in modifying the HVAC system including HEPA filter grid to upgrade the room to comply with the new requirements of products manufactured in the vials filling area.

Particle Counters System-Building D

This project consisted of the design, fabrication, installation and validation of an air monitoring system for suspended particles inside manufacturing rooms.  This monitoring system was installed inside Class 100 and 10,000 rooms to comply with GMP and ISO standards.

Piping Upgrade Project – Room 2340

Upgrade of the piping systems such as nitrogen, vacuum and ventilation within a formulation area to make them more reliable.

Ceph Area Improvement 
Remodeling of an existing production and packaging facility.

Automated Quality Assurance
AQAI (Automated Quality Assurance) Remodeling of five existing packaging lines. Upgrade existing packaging lines to comply with the latest FDA requirements related to product quality.  These guidelines refer to bar coding, lot number, expiration date, product presence, product color, product shape, check weighing, and metal detection, among others.  FAT/SAT Validations were included in the project.

Building D Upgrade
Remodeling of Class 100 room including installation of a new filling machine for vials, new formulation room and installation of glass lined reactors.

Cold Storage – Building D
This project consisted of the design, fabrication and installation of a 140 ft. long, 16 ft. wide, 40 ft. high refrigerated warehouse inside an existing facility for the storage of finished goods.

Services: CM and Engineering Support