Masy Biorepository Storage

Measurable Quality for Life Sciences
cGMP BIOSTORAGE
‣ Stability Studies / Accelerated Aging (40°C – 70°C)
Your Comprehensive Partner for cGMP Production Services.
Masy BioServices
10 Lomar Park
Pepperell, MA 01463
(978) 433-6279 | [email protected]
The efficacy and integrity of biologic samples and life science products
are contingent upon proper handling and storage. Improperly-managed
clinical samples can impede the costly and time-consuming process of
bringing an important new product to market, and active products can
be rendered ineffective by a difference of just a few degrees. Proper
biorepository storage affects both patient health and your bottom line.
Proper storage of your condition-sensitive materials requires significant
space, overhead, and management focus. Can your team and facility
create the right conditions for the best long-term and temporary storage
of your most critical samples and products? Choose Masy BioServices for
your secure, off-site biostorage needs.
You can have confidence that the materials you entrust to us will remain
safe, secure, and compliant to your specifications until you need access
to them again.
©2015 Masy BioServices. All rights reserved.
0300-0001-x1 4/2015
‣ Stability Storage (25°C – 40°C)
‣ Controlled Storage (20°C – 25°C)
‣ Ambient Storage (15°C – 30°C)
‣ Refrigerated Storage (2°C – 8°C)
‣ Freezer Storage (-20°C)
‣ Ultra-Cold Storage (-75°C)
‣ Cryogenic LN2 Storage (-135°C/-196°C)
Biostorage with Masy offers confidence at all temperatures.
www.masy.com
Masy’s biorepository offers secure cGMP storage at precisely-controlled conditions.
Choose Masy BioServices for Security & Stability.
Masy’s continuously-monitored biorepository facility securely stores clinical study samples, vaccines, drug compounds,
production stock, medical devices, and other biologic products under precisely-controlled temperature and humidity
requirements, from controlled room storage through cryogenic freezing, ensuring the integrity of these valuable
materials.
When you store your clinical samples, biologics,
pharmaceutical products, or medical devices with Masy,
you should feel as confident as if your materials never
left your care. Our state-of-the-art cGMP storage facility
offers unparalleled security for your most sensitive
materials.
Off-site cGMP biorepository storage allows you to free up your valuable laboratory and production space for new
projects. Let our experienced team of biorepository professionals manage your materials, and remove the burden of
inventory oversight and chamber monitoring and maintenance.
Masy BioServices can also perform stability testing at all standard ICH setpoints, execute custom stability testing
protocols, and perform accelerated aging studies, verifying the useful life of your products with confidence.
Focused on Biostorage Management
Cold Chain of Custody Logistics
Located in the greater Boston metro area, our
biorepository is readily accessible by multiple major
highways and international airports. We use pre-qualified
shipping containers with calibrated shipping loggers to
ensure that your materials remain in compliance from
your door to ours.
Successful management of environmental storage chambers may not
be your core competency, but it’s one of ours. We have the knowledge,
experience, systems, and staffing to manage a world-class biorepository.
Leave the administration of your storage to us, and focus your attention
and efforts on what will drive your business forward.
For regional customers, we offer validated ground
transport, refrigerator / freezer truck transportation, and
same-day pick-up and delivery options.
Cost-Effective Biorepository Operations
Our validated inventory management system, Freezerworks, provides paperless tracking of product locations.
With more than 65,000 cubic feet of capacity, we can more easily
share the investment, staffing, and infrastructure overhead required
to operate a cGMP biorepository across our entire facility than an
individual department or company could with only a few chambers —
offering an economy of scale not available with smaller biorepository
operations.
24/7 Video Surveillance
Reclaim Valuable Laboratory & Production Space
Free up your limited lab space by moving your long-term storage
materials to our biorepository. Our well-connected suburban location
allows us to offer you the best of both worlds: easy access to your
materials when you need them, without the associated higher cost of
urban real estate.
Efficiency & Sustainability
Our custom-designed walk-in refrigerator, freezer, and ultra-cold
biorepository vaults are dramatically more efficient than an equivalent
volume of traditional upright chambers, offering the same level of
security and integrity with reduced cost and less environmental
impact.
In-House Calibration & Qualification
We don’t need to hire third-party service providers to maintain our
chambers; our in-house calibration and qualification teams have the
equipment, expertise, and staffing required to keep our biorepository
operation running at peak performance.
Inventory Control
All exterior and interior biorepository doorways are constantly monitored by video camera surveillance.
Multilayered Physical Security
All building entrances are continually secured by keycard-activated locks with auditable access trails. Access to
biorepository facilities is limited to specifically authorized and trained employees with the correct access credentials.
Each individual biorepository chamber is additionally secured with a unique physical lock.
CyberLock Electronic Access Control
Each individual chamber is secured with a CyberLock smart lock, with a unique ID and an encrypted access code.
Locks have no pick-able keyway, and are tamper- and torque-resistant. Authorized biorepository personnel are issued
individually-traceable CyberLock smart keys, which can be authorized for specific chambers, days, and times. Audit
trails record both authorized openings and denied attempts.
Continuous Monitoring
All biorepository facilities are constantly monitored by our proprietary Masy Commander system, with temperature and
humidity checks every 10 seconds. In the rare event of an excursion, response team personnel are notified via SMS
text, e-mail, cellular, and landline notifications.
Triple-Redundant Cooling Backup
Our walk-in vaults have dual redundant mechanical refrigeration at each temperature condition, with a direct-injection
LN2 backup.
Dual-Redundant Power Backup
Two independent generators with failover capability ensure 8 days of off-grid facility operation.
Store your critical materials today with Masy BioServices.