The pharmaceutical industry is marked by rapid product introductions and the drive to optimize secure storage footprints while managing compliance. CustomVault’s Pharmaceutical Practice Group is focused on the unique requirements of Drug Enforcement Administration (DEA) validated high-security storage for pharmaceutical manufacturing, warehousing, 503B compounding pharmacy and laboratory applications.
What You Need
In accordance with the Code of Federal Regulations 21 CFR 1301.72, the governing specification for pharmaceutical applications, controlled substance security dictates the following:
Schedule I and II
- Modular vault systems complemented by GSA Approved Class 5 and AR5 vault doors and day gates (note that these parameters also apply to mobile vaults)
- TL 30 safes
- Electronic Security
Schedule III, IV and V
Proper execution of the details is critical for compliance and the viability of your pharmaceutical business. Those in the know seek partners with expertise and experience specific to pharmaceutical solutions because there is no room for error.
What We Deliver
CustomVault has been building and expanding DEA validated vaults for major U.S. pharmaceutical manufacturers and distributors for over 30 years, and has offered solutions for 503B compounding pharmacies and laboratories as well. We anticipate the evolution of your vault and security needs due rescheduling, product introductions, and merger and acquisition activity; responding with expedience and delivering real solutions. And we have never failed a DEA inspection.
CustomVault is not only expert at configuring solutions meeting DEA requirements, but also in optimizing efficiency for pharmaceutical distribution and manufacturing operations:
We innovate to meet your needs:
- CustomVault introduced the HighBay™ vault system; the first DEA validated, multi-story solution specifically designed to accommodate the pallet racking and forklift requirements of the pharmaceutical segment. This is a complement to our LightWeight™ and MegaVault™ alternatives.
- CustomVault thinks out of the box when it comes to pharmaceutical vault interiors. Our customized racking systems support storage optimization, and cold box storage accommodates the growing need for temperature control.
And we successfully manage:
- Racking and Storage Requirements. CustomVault reviews requirements to design the right racking system for you, and determine the optimal size and configuration of the DEA validated pharmaceutical vault.
- Traffic Patterns. CustomVault evaluates access requirements for forklifts, pallet jacks and warehouse personnel to suggest vault access patterns, rack layout and door configuration.
- Site Access Conditions and Structural Load Challenges. CustomVault evaluates site access and existing conditions to ensure that every option is considered in optimizing both the cost and functionality of the vault solution.
- Aggressive Timetables. Given our in-house resources, CustomVault has the quickest turnaround time in the industry and has met the most aggressive construction schedules. Shop drawings with structural and engineering evaluation can be provided in as little as two days.
- Limiting Disruption to Existing Operations. CustomVault systems go up quickly and cleanly, minimizing interruption to ongoing operations.
We begin by providing consulting services for all pharma clients before executing a vault or security solution. Site assessment, analysis and review of industrial and governmental requirements, physical surveys, applications, architectural drawings, planning, and budgeting are all part of our package.
Contact our Pharmaceuticals Expert at 866.431.7646 or reach out here: firstname.lastname@example.org