Frequently Asked Questions
Temperature-sensitive product guardianship involves an exacting approach to handling and transporting precious biopharma materials and products. Instead of meeting minimum safety and security requirements for temperature-sensitive materials, Sentry provides a highly specialized level of security and assurance throughout every stage of storage and handling. Guardianship results in the successful handling, transport and storage of temperature-sensitive products and materials.
Sentry’s processes extend beyond pharmaceutical cold chain management to create a value chain, affecting everything from raw materials storage to resolving import/export issues. Sentry seamlessly couples internal and external expertise to develop and deliver unprecedented value in storage, packaging, material management, distribution and process management of temperature-sensitive materials and legend drugs.
You should turn to Sentry when temperature sensitivity is a vital factor in your biopharma products or components. Sentry is ideal for any pharmaceutical or biotech interest that manages highly sensitive materials, components and products for purposes of clinical trials, product development, manufacturing or commercial distribution. Unplanned temperature excursions at any point in the legend lifecycle can cause devastating setbacks-losing valuable time, wasting resources and costing dollars. If you need certainty that your investment in materials or research won’t be affected by temperature deviation, you need Sentry.
If you need contract warehousing and/or custom packaging services for consumer goods or low-cost commodities where temperature sensitivity is a low-priority issue, you may not need Sentry. Sentry exclusively serves the healthcare industry. Many other companies store, transport and package various items without the level of expertise, precision and security that Sentry provides.
Sentry provides biopharma services for the following organization types:
- Contract manufacturing organizations (CMOs)
- Contract research organizations (CROs)
- Governments, hospitals and universities
- Medical device manufacturers
- Nonprofits and humanitarian agencies
- Pharmaceutical and biotechnology firms in research, development or manufacturing phases
- Pharmaceutical wholesalers, distributors and suppliers
- Vaccine manufacturers
Sentry provides biopharma solutions for the following product types:
- Active pharmaceutical ingredients (APIs)
- Controlled substances
- Finished drug products
- Medical devices
- Packaging materials (boxes, cases, labels, foil, etc.)
- Semi-finished products
- Shipping materials (envirotainers, gel packs, foam, etc.)
- Master and Working Cell Banks
- Commercial order fulfillment
- GMP storage and distribution
- Pharmaceutical supply chain management
- Secondary pharmaceutical packaging
- Ambient: +15°C to +30°C
- Controlled Room Temperature: +20°C to +25°C
- Refrigerated: +2°C to +8°C
- Frozen: -15°C to -25°C
- Low-Temp Frozen: -35°C to -45°C
- Custom Frozen: -40°C to -60°C
- Custom Ultra-Low: -65°C to -85°C
- Ultra-Low: -70°C to -90°C
- Vapor Phase: <-135°C
- Custom Temperature Solutions: 0°C to <-135°C
By providing pharmaceutical supply chain management, Sentry contributes confidence, efficiency and compliance. Sentry instills confidence in its clients by executing outsourced pharmaceutical operations with the highest level of reliability and responsiveness. With a continuous improvement culture, Sentry develops and refines client solutions that meet deadlines and budget expectations. Key business drivers are identified and targeted for process improvement when appropriate. Finally, Sentry built its service offering on a foundation of quality, with consistent audits and education that positions Sentry as a leader in compliance.
A team of life sciences and project management professionals founded Sentry BioPharma Services in 2004. The founders developed Sentry to meet the rapidly growing demand for storage and management solutions in the pharmaceutical and biotechnology sectors. Sentry was conceived specifically to protect temperature-sensitive products throughout the pharmaceutical supply chain.
Sentry BioPharma Services is located in Indianapolis, adjacent to the Indianapolis International Airport. Indianapolis International ranks as the eighth largest cargo airport in the U.S. and houses a major FedEx hub, which accommodates late drop-offs. Sentry’s facility is accessible to 75% of all U.S. businesses within a one-day drive, and it occupies a Foreign Trade Zone, which can reduce duties, inventory taxes and brokerage fees.
Sentry operates a 83,000-square-foot facility, devoting 77,000 square feet to GMP warehousing and distribution. Sentry incorporated readiness for expansion and the addition of new technology into its original design. The facility maintains dedicated and restricted storage space, with a separate location for secondary packaging operations, and enhanced security for high-risk products.
Sophisticated physical and data security measures protect client materials throughout all stages of storage, handling and distribution. Sentry’s robust security program encompasses market trends, industry best practices and audit feedback. For specific security-related questions, please contact Sentry BioPharma Services at 1-866-757-7400 or via email at firstname.lastname@example.org.
Sentry utilizes industry-leading temperature-monitoring equipment and building management systems within its GMP facility. Backup systems are capable of running all essential systems. Sentry also conducts ongoing assessments of all SOPs (standard operating procedures) and processes. For specific temperature-monitoring questions, please contact Sentry BioPharma Services at 1-866-757-7400 or via email at email@example.com.
There are many, including:
- Immediacy. Sentry acts quickly to anticipate client needs or resolve them as they arise. Sentry operates under the continuous expectation that neither time nor quality can be sacrificed.
- Quality. Top-tier service providers present procedures and quality components specific to the service area. With multiple clients, insurance and governmental audits, Sentry’s quality program meets all and exceeds many of our clients’ quality expectations.
- Risk management. Outsourcing reduces risk by reducing the impact and/or probability of negative occurrences. Sentry’s core competency is protecting product integrity throughout the supply chain. Sentry understands the risks and has processes to mitigate these risks.
- Service. Sentry’s proficiency and responsiveness enable clients to stay within timelines while devoting resources to their core competency. Sentry also helps clients capitalize on unique or under-utilized processes such as Foreign Trade Zone designation, customs bond, FDA labeler code and controlled substance registration.
- Deliver scalable, reliable spaces and processes that quickly and easily accommodate changing pharmaceutical needs.
- Minimize risks associated with temperature deviation in all stages of material storage, handling, distribution and packaging for biopharma products.
- Monitor, update and validate all processes and maintain the integrity of all systems and materials.
- Safely and securely store and distribute materials and legend drugs throughout the pharmaceutical product lifecycle.
- FDA-registered drug establishment, PMDA accredited, compliant with FDA ,EMA, WHO cGMP and GDP requirements.
- Local: 1-317-856-5889
- International: 001-317-856-5889
- Fax: 1-317-856-4552
- Sales/Service Inquiries: firstname.lastname@example.org
- General Inquiries: email@example.com
- Sentry BioPharma Services, Inc.
- 4605 Decatur Boulevard
- Indianapolis, IN USA 46241