Sterile Chemical Manufacturing Division
VAI’s Sterile Chemical Manufacturing Division (SCMD) has addressed the needs of the Pharmaceutical, Biotechnology, and Healthcare industries by designing a complete range of sanitizers, sterile disinfectants, sporicides, lubricants, cleaners, and process cleaners for controlled manufacturing areas. VAI’s SCMD products are used at over 500 pharmaceutical and biotechnology organizations worldwide.
SCMD manufactures a complete range of cleaning agents and disinfectants that are used daily in cleanroom operations. All VAI chemical manufacturing operations are completely validated, and assure that critical validation parameters are within tolerance to assure product integrity. VAI capabilities for manufacturing products include the ability to fill aerosol, bulk, and unidose packages in a classified filling operation. Our filling operations are coupled with the validated and proven ability to irradiate a final product. Assurances are taken in every aspect of chemical manufacturing concerning sterility and particulate removal. Our chemical manufacturing operations mirror Current GMP’s and enforces the adherence to USP methods and specifications for testing of all manufactured products. VAI is an EPA and FDA registered facility and possesses worldwide registrations.
SCMD has taken another advancing step in product quality assurance by incorporating USP Water for Injection (WFI) into the majority of our products. The validated WFI systems in our chemical manufacturing facility incorporate an added advantage to the use of our products. The mission of VAI’s SCMD is to manufacture top-of-the-line quality products that address any regulatory requirements demanded.
SCMD has chemical manufacturing capabilities to produce both VAI products and contract custom manufacturing designs. VAI’s SCMD uncompromising cGMP manufacturing style and our complete adherence to USP specifications has assured outside organizations that their products will not only be produced and tested as sterile, but moreover, their product will be completely documented and validated. VAI’s SCMD is proud of our history and track record.
Environmental Control Monitoring Division
VAI’s Environmental Control Monitoring Division (ECMD) has addressed the needs of the Pharmaceutical, Biotechnology, Semiconductor, and Electronics industries by designing a complete range of viable and non-viable air sampling equipment.
SMA® Microbial Sampling Systems are designed to sample air within the clean room environment for the purpose of discerning the level of viable contamination that is present in a volume of air. As one of the premier sampling methods in the pharmaceutical and biotechnology industries for over 30 years, SMA Microbial Sampling Systems offer a complete range of products to meet all requirements for quantitative microbial air testing. The SMA viable environmental monitoring portfolio includes SMA Atriums®, SMA OneTouch® ICS, SMA MicroPortable® Air Samplers, SMA Compressed Air/Gas Samplers, and SMA OneTouch Command Systems.
The SMA OneTouch® ICS is a computerized, automated viable air monitoring system that controls calibrated, precise air sampling through individual or multiple SMA Atriums. The SMA OneTouch ICS provides the ability to test multiple locations in a facility-wide monitoring system through a touchscreen interface. In addition to our facility wide environmental monitoring systems, the SMA MicroPortable Air Sampler is a battery operated unit that provides portability for the sampling of viable airborne contaminants. The SMA Compressed Air/Gas Sampler is an automated and portable device that is designed to assist in obtaining the microbial levels of compressed air and gas systems.
In addition to a comprehensive viable environmental monitoring portfolio, VAI offers a complete line of non-viable particle counters. VAI’s Non-Viable Environmental Monitoring systems are used for continuous or period monitoring of particle counts in cleanrooms and critical environments. The SMA MicroParticle ICSTM instruments offer unmatched environmental control by utilizing the latest innovations in particle counting technology and by integrating several features not found in other Particle Counters. SMA MicroParticle ICS instruments are available in three models: HandHeld, Table Top, and Wall Mounted models. Remote models are also available for integration into facility monitoring systems.
ECMD also manufactures the H-Y Tumble Drum® which is used for testing and disseminating the inherent contamination levels of products deemed suitable for controlled environments.
High quality, durable and comfortable cleanroom garments
Custom product design, sewing and packaging available
Disposable Products Manufacturing Division
VAI’s Disposable Products Manufacturing Division (DPMD) has addressed the needs of the Pharmaceutical, Biotechnology, Medical Device, Electronics, and Healthcare industries by designing a complete range of sterile and non-sterile disposable garments, facemasks, saturated and non-saturated wipers, and UCAN packaging which are manufactured through a Clean Manufacturing Processes.
The Clean Manufacturing Process incorporates all DPMD products. They are processed and packaged in cleanroom facilities from beginning to end. This manufacturing style assures that all products are handled in the cleanest fashion available for this type of operation. Subsequently, VAI’s disposable garments, masks, and packaging materials are one of the lowest particulate inherent products in the marketplace. After manufacture they are gamma irradiated in order to assure sterility.
DPMD has responded and met the demands of professionals in the industry since 1985. Our custom manufacturing capabilities assure that the clientele will be able to request changes to standard products to have custom items manufactured and packaged specifically for their needs. With the first response to the need for wipers in cleanroom operations to our latest response to innovate and redesign our sterile garments, VAI has continually served the industry by addressing the challenges seen.
Easy2Gown System® – The easiest, least complicated way of gowning is the best. Easy2Gown is VAI’s patented gowning system that was designed so there is minimal manipulation and virtually no operator contact to the outside of the gown. The Easy2Gown system is offered in all of VAI’s garments, therefore, reducing costs and time in all operations that use our garments.
Aseptic Processing, Inc.
Since 1981, Veltek Associates, Inc. has played an innovative role in the pharmaceutical, biotechnology, and medical device industries by partnering with clients to develop strategic products and service that have improved operations and reduced costs associated with the ingress of contamination. During the history of the company, VAI has 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 over three decades of operations, VAI has not only developed innovative products and services but also the know how for assuring successful and compliant systems to monitor and control contamination.
In 2001, after many years of refinement and development, VAI introduced a unique and specialized value added advantage for it’s clientele know as VAI Consulting Services. In 2003, due to its enormous growth, the division was reorganized into Aseptic Processing, Inc. (API), which 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 organization, 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. API was also responsible for the cleaning and disinfection training that was conducted to the U.S. Food and Drug Administration’s CDER and CBER divisions in 2001-2004.
Uniquely, the division works to combine all contamination control aspects within an organization into one system that is both compliant, effective and assures repeatable success.
Custom cart systems to fit your operation
Cellulose free, synthetic writing substrate
Cleanroom compatible tags, logbooks, notebooks, forms, and labels
Custom printed documentation to fit your operation’s needs
Tracking system that manages the location, data, and workflows associated with assets in a compliant, accurate manner
RFID tags, scanners, and tracking software
Cart Documentation Tracking Division
VAI’s Cart, Documentation, Tracking Division (CDTD) has addressed the needs of the Pharmaceutical, Biotechnology, Medical Device, Electronics, and Healthcare industries by designing a complete range patented cart transfer equipment, customized cleanroom documentation including logbooks, labels, paper, forms, notebooks, and tags, a patented cleanroom printing systems, and patented chemical resistant RFID tags, readers, and software.
For countless years GMP firms have struggled with the problematic issue of “how do we transfer carts from the exterior unclassified area or the adjacent lesser grade (C/D) classified area to the Grade A/B area?” Cleaning and subsequent disinfection of the upper portions of carts, while labor intense, are manageable. However, the bases and wheels have been one of the most problematic situations in the industry to date. The Cart2Core® System reduces the possibility of particulate and microbial contamination transfer from a lesser classified area to the subsequently cleaner area of the operation. The Cart2Core System allows for transfer of the cart top to another previously cleaned, disinfected, or sterilized cart base located in the next and cleaner classification. Therefore, contamination from lesser classifications coming in contact
with the floor or personnel is reduced.
Furthermore, GMP firms have a constant struggle with the task of reducing fibers, particulates, and microorganisms within classified areas. A main source of this problem is paper products used to document operations. Characteristically, paper products shed a high level of fibers and particulates. These fibers and particulates can wreak havoc on any aseptic operation by corrupting environmental conditions and final product. In response, VAI has developed an innovative way to address and solve questions surrounding particulate and fiber shedding from cleanroom documentation with our Cleanroom Documentation Systems product lines.
Finally, Within any pharmaceutical, medical device, biotechnology, or healthcare operation, traceability and accuracy are of prime importance. However, since 2004, the Food & Drug Administration (FDA) has identified numerous and notable pitfalls with traceability throughout processes from raw material receiving, manufacturing steps, asset identification, and documentation, to end user delivery and drug counterfeiting. Additionally, cleanroom or aseptic manufacturing firms are concerned with the ingress of contamination. Implementing traceability systems can bring unwanted contamination into cleanroom manufacturing facilities. The ingress of contamination can lead to a costly investigation, require more man-hours, and/or slow down the manufacturing process. To mitigate, VAI developed Core2Scan. Core2Scan® is a complete RFID tracking solution designed for the pharmaceutical and biotech industry. Core2Scan® can track assets, people, raw material, and inventory. The asset tracking piece incorporates asset management tools for monitoring equipment calibration, PM, and service requests. This solution can also be used for process improvement, allowing you to track asset and personnel flow throughout your facility.