During the history of VAI, we have manufactured and developed over 500 strategic and critical contamination control products, systems and services. These innovative solutions are used by most GMP organizations worldwide. In 2001, after many years of refinement and development, VAI introduced a unique and specialized value-added advantage for its clientele known as VAI Consulting Services. In 2003, due to its enormous growth, the division was reorganized into Aseptic Processing, Inc. (API). API is the consulting and training division of Veltek Associates, Inc.
The mission and key focus of the division is to lead the industry in specific contamination control and environmental monitoring systems. Unlike many consulting organizations, API focuses specifically in the areas of Cleaning and Disinfection Systems, Disinfectant Validation Services, Component Entry Systems, Environmental Monitoring Systems, Aseptic Processing Systems, Media Fills, and Personnel Training Systems. API has assisted a multitude of pharmaceutical, biotechnology, and medical device organizations worldwide.
VAI Laboratories was established to assist our customers by providing microbiological testing services ranging from the identification of microorganisms to antimicrobial effectiveness studies to prove the effectiveness of selected disinfectants.
The successful operation of a cleanroom environment is dependent on the exactness of the information available and the implementation of a plan of action from such information. Pharmaceutical, Biotechnology, and Healthcare professionals have been required by the FDA to address known contamination within their facility and develop a validated plan of action to remove such contamination. This requirement will not change in the future. In fact, qualifications for clean room operations will only become more stringent as time progresses.
VAI Laboratories offers the following services in conjunction with the use of VAI products: Time Contact Kill Studies, Disinfectant Validation Services, Microbe Identification Service, and Consulting.
Selecting an appropriate detergent to clean your specific process soil is paramount to the overall selection process. The detergent selected may also play a significant role by impacting other operational issues such as substrate compatibility, effluent restrictions, worker safety, chemical usage, inventory, storage, and disposal concerns. VAI’s CORE (Critical Ongoing Residual Evaluation) program addresses detergent selection from a scientific rationale approach along with an understanding of the key operational issues facing your manufacturing facility today. The focus of the program is to provide our clients with a specialized laboratory service that can assist them by performing off-site product contact cleaning analysis studies as an external service. Your manufactured process soils are applied to stainless steel or glass coupons in our unique CORE Analysis Test Apparatus, in a worst case scenario, and soaked to determine the ultimate success of different cleaning chemistries trialed.
The CORE System provides the requirements necessary to meet both internal objectives and external regulatory expectations by providing you, the end user, sound scientific rationale in your detergent selection process. VAI’s comprehensive pharma – biotech cleaning program also provides analytical methods of detection specific to our GMP detergents as well as compatibility, TOC curves, conductivity curves, toxicological reports, and other controlled documents to help support your cleaning validation plans.
USP 797 Compliance
Veltek Associates, Inc. covers every aspect of cleaning and decontaminating necessary for full compliance to USP including consultation from industry experts on setting up and maintaining aseptic processes during the compounding of sterile products. VAI has a complete line of sterile cleaning agents and disinfectants with easy to use sterilizable cleaning systems. The Core2Clean® Plus System addresses the cleaning and disinfection of environmental surface areas. The SimpleMix® System provides easy-to-use disinfectants in a pre-measured container system. In addition, VAI offers complete line of sterile, individually packaged, saturated wipes.
To further address the requirements, VAI provides a unique innovative gowning system to address aseptic gowning requirements. Additionally, the easy to use SMA air samplers are an accepted industry standard that simplifies microbial air testing in aseptic compounding areas. As the compounding pharmacy industry moves forward to require greater control of environmental production areas, be assured VAI is one step ahead with innovation and support.
You can be sure that VAI’s Innovative cleanroom Solutions will be there to help you with our “Full Circle Approach” to USP . For Veltek Associates, Inc. it’s simple: innovation is about listening to industry challenges.