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NEST Scientific — The Trusted Partner for 503A & 503B Compounding Pharmacies

As the regulatory landscape tightens and patient demand for advanced injectable therapies continues to grow, 503A and 503B compounding pharmacies need partners who understand compliance, quality, and scalability.

NEST delivers all three.

From pen injectors and RTU cartridges to fully validated automatic injection systems, NEST provides drug-device combination solutions designed for safety, efficiency, and regulatory confidence.

Understanding the Needs of 503A and 503B Pharmacies

• 503A Pharmacies focus on patient-specific compounding with flexibility and customization.

• 503B Outsourcing Facilities operate under CGMP requirements, producing larger batches for healthcare systems and clinics.

Both require:

• Reliable supply chains

• Validated, compliant medical devices

• Accurate dose delivery systems

• Documentation to support inspections and audits

• Safe, patient-friendly self-administration solutions

NEST was built with these requirements in mind.

Advanced Pen Injector & Self-Administration Platforms

NEST offers a complete portfolio of injection platforms compatible with medications such as semaglutide, liraglutide, insulin, FSH, and other hormone or GLP-1 therapies commonly compounded in 503A and 503B settings.

Product Portfolio Includes:

• Disposable Pen Injectors (Standard, SP, TSA)

• Self-Locking Pen Injectors (100 IU)

• Fixed-Dose Pen Injectors

• Prefilled Automatic Pen Injectors (Two-Step & Three-Step)

• RTU Cartridges (EO or steam sterilized)

• Press-Fitting & Assembly Equipment

For compounding pharmacies offering weight management, hormone therapy, fertility treatment, or metabolic therapies, these delivery systems enhance both compliance and patient experience.

Built for Compliance: Certifications & Regulatory Support

Compounding pharmacies cannot afford regulatory risk. NEST provides a strong compliance foundation:

• ISO 9001 / ISO 13485 certified

• ISO 11137 sterilization validation

• FDA registration

• CE certification

• MDSAP Five-Country Certification

• USA 510(k) cleared devices

• Canada MDL licenses

• China Class II Medical Device Certificates

• FTO (Freedom to Operate) analysis covering U.S., U.K., Europe, and China

Production lines follow GMP standards with third-party monitoring throughout the process.

For 503B facilities operating under FDA CGMP standards, this level of validation and documentation support is critical during audits and inspections.

Comprehensive Product Validation

NEST conducts extensive verification testing in accordance with ISO 11608 standards (pen injector requirements).

Testing includes:

• Final dose accuracy

• Free-fall dose accuracy

• Injection start force

• Cold / warm / humid / frozen environmental testing

• Vibration testing

• Lifecycle testing (4,500+ cycles)

• Needle compatibility & torque validation

• Leakage testing

• Stability verification (1-, 3-, and 5-year accelerated aging)

This ensures pharmacies can confidently provide drug-device combinations that meet performance expectations even under challenging storage and transport conditions.

Full In-House Manufacturing = Faster Customization

Unlike many suppliers that outsource critical components, NEST operates a fully integrated industry chain:

• Independent mold design & manufacturing

• Polymer material expertise (PP, PC, medical-grade plastics)

• Automated injection molding

• Automated assembly lines

• Optical inline inspection

• Three-coordinate measurement systems (ZEISS)

• Industrial CT scanning for precision validation

Facilities include:

• 10,600㎡ Class 100,000 cleanroom

• 3,600㎡ Class 10,000 cleanroom

• 2,300㎡ pen injector controlled workshop

For 503A pharmacies requiring smaller customized batches or 503B facilities needing scalable production, this flexibility reduces lead time and ensures consistent quality.

RTU Cartridges Designed for Sterility & Safety

NEST RTU cartridges are:

• 100% inline optically inspected

• Available pre-sterilized (SAL 10⁻⁶)

• Compatible with EO or steam sterilization

• Manufactured in GMP-controlled cleanrooms

• Packaged in Nest-pack configurations to reduce breakage

For outsourcing facilities managing sterile injectables, validated RTU components reduce processing burden and contamination risk.

Assembly Equipment for 503B Scaling

For larger outsourcing facilities, NEST also offers:

• TSA disposable pen press-fitting equipment

• Prefilled automatic pen injector assembly systems

• Automated cartridge insertion lines

• Vision inspection systems

• Pressure and performance testing stations

This enables 503B pharmacies to move toward scalable, semi-automated drug-device combination assembly while maintaining compliance and traceability.

Global Supply Chain Stability

NEST supports U.S. customers through:

• U.S. East Warehouse – Woodbridge, NJ

• U.S. West Warehouse – Phoenix, AZ

• Long-term supply contracts

• Safety stock programs

• Full batch traceability

• Retained sample programs

• Transportation inspection controls

For compounding pharmacies managing fluctuating demand in GLP-1 or hormone markets, supply continuity is a competitive advantage.

Why 503A & 503B Pharmacies Choose NEST

1. Compliance-Driven Manufacturing

GMP production, global certifications, and documented validation support inspection readiness.

2. Dose Accuracy & Patient Safety

Extensive performance testing ensures reliable administration.

3. Customization Capability

Dose units, graduation marks, colors, packaging, and branding can be tailored.

4. Scalable Solutions

From small compounding operations to high-volume outsourcing facilities.

5. End-to-End Support

From RTU cartridges to finished pen injector systems and assembly equipment.

The Bottom Line

In today’s environment, compounding pharmacies need more than a component supplier. They need a strategic manufacturing partner that understands compliance, sterility, performance validation, and supply chain security.

NEST delivers:

• Fully validated pen injector systems

• Drug-device compatibility

• Regulatory-ready documentation

• Scalable production capabilities

• Global distribution with U.S. infrastructure

For 503A and 503B pharmacies looking to enhance their injectable offerings while reducing regulatory risk, NEST is not just a supplier  it’s a long-term partner in precision, compliance, and patient safety.

NEST Enters a New Era of High-Standard Sterilization : Core Sterilization Equipment Upgrade

At NEST Scientific, delivering safe, reliable, and high-quality products begins with uncompromising standards in manufacturing and sterilization. In response to growing global demand for higher and more verifiable sterilization performance, NEST has completed a major upgrade to its core sterilization infrastructure marking an important milestone in our continuous commitment to quality excellence.

Through strategic collaboration with Futeng’s professional irradiation platform, NEST has now established a mature, stable, and fully validated irradiation sterilization solution system designed to meet the rigorous needs of medical devices, biopharmaceutical products, and laboratory consumables.

Introducing the IBA Rhodotron® TT300 Dual-Beam Accelerator

Futeng has introduced the internationally advanced IBA Rhodotron® TT300 dual-beam accelerator from Belgium, one of the most respected irradiation systems in large-scale industrial sterilization. This state-of-the-art platform integrates electron beam (E-beam) and X-ray irradiation technologies into a single system, significantly enhancing:

• Certified by ISO 11137

• Sterilization capacity

• Process stability

• Dose accuracy

• Product compatibility

The result is a high-standard, traceable, and verifiable sterilization solution that supports the demanding quality expectations of regulated global markets.

Built for High-Throughput, High-Control Applications

The Rhodotron® TT300 is a high-power model specifically developed by IBA for continuous, industrial-scale sterilization. It is engineered to deliver tightly controlled doses while balancing efficiency, safety, and process flexibility making it ideal for large-volume manufacturing environments.

Its dual-beam design allows operators to switch between E-beam and X-ray modes, enabling optimization based on product structure, density, packaging, and validation requirements. This flexibility greatly expands the range of products that can be sterilized using a single, robust platform.

Key Advantages of the Rhodotron® TT300 Platform

• Compatible with products of varying densities and geometries

• Leading X-ray performance with excellent penetration and dose uniformity

• High efficiency and energy-saving operation

• Industrial-grade reliability for long-term continuous use

• Dual assurance of regulatory compliance and precise dose control

Broad Application Coverage

The upgraded irradiation system supports sterilization of products across multiple sectors, including:

• Medical devices and single-use consumables

• Biopharmaceutical and laboratory-related products

• Aesthetic medicine and health protection products

• Research and industrial-use products

What This Upgrade Means for NEST Customers

The introduction of the Rhodotron® TT300 delivers tangible benefits throughout the product life cycle:

• Improved sterilization consistency and reliability

• Reduced risk of variation and sterilization blind spots

• Stronger support for high-standard product development

• Enhanced compliance with international regulatory expectations

• Increased production capacity and supply stability

• Greater confidence in product safety and performance

Advancing Quality, Compliance, and Global Readiness

This core sterilization equipment upgrade represents more than a technical enhancement; it reflects NEST’s long-term strategy of investing in advanced manufacturing technologies that strengthen quality systems and customer trust.

By leveraging the capabilities of the IBA Rhodotron® TT300, NEST further reinforces its ability to deliver safe, consistent, and globally compliant products supporting partners worldwide with reliable solutions they can depend on.

 

Detail-Driven Design for More Efficient Results

Enhancing Everyday Pipetting Through Smarter Design

At NEST Scientific, product innovation is driven by real-world laboratory needs. Based on extensive user feedback, we have systematically upgraded the structure of our pipette tip boxes focusing on practical details that make everyday workflows easier, safer, and more efficient.

These enhancements improve handling, stacking, and organization without altering how you access tips or perform experiments. The result: a more user-friendly experience that supports productivity at the bench.

Even small design improvements can make a big difference in busy laboratory environments. Our latest tip box upgrades center on three key areas:

1. Easier Handling

We’ve introduced ergonomic structural features at key points of the tip box to provide a more secure grip.

• Improved stability when handling with or without gloves

• One-handed pick-and-place operation

• Reduced risk of slipping or accidental drops

These enhancements make routine pipetting tasks smoother and more reliable, even in fast-paced workflows.

2. Easier Stacking with Improved Anti-Slip Performance

The lid-top and base structures have been optimized for better alignment and stability.

• More precise positioning when stacking multiple boxes

• Minimized sliding between stacked units

• Greater stability during storage, transport, and benchtop use

This redesign helps maintain an organized workspace and reduces the chance of spills or tip contamination.

3. Unified Color & Standardized Form Factor

To support mixed-brand laboratories and efficient storage:

• External dimensions are standardized to match most mainstream tip boxes

• Tip boxes from different brands can be stacked together

• Unified appearance and color scheme simplify centralized lab management

Importantly, these changes do not affect tip retrieval methods, sealing performance, or existing experimental workflows.

NEST Pipette Tips: A Complete Product Portfolio

NEST pipette tips are engineered to support a wide range of laboratory applications, including routine pipetting, low-binding workflows, and automated liquid handling. Our portfolio spans volumes from 10 μL to 1000 μL and includes:

• Standard and extended-length tips

• Filter tips and conductive tips

• Compatibility with manual pipettes and high-throughput automation platforms

Multiple packaging formats include racked, bulk, and stacked which are available in both sterile and non-sterile options to meet the needs of research, clinical diagnostics, and biopharmaceutical laboratories.

Key Advantages of NEST Pipette Tips

• High-quality materials: Medical-grade polypropylene (PP), USP Class VI compliant

• Accurate and stable pipetting: Smooth inner surfaces with hydrophobic design to reduce liquid retention

• Clean and safe: DNase/RNase-free, pyrogen-free, and endotoxin-free

• Excellent compatibility: Standardized interface fits mainstream pipettes and automation systems

• Reliable filter protection: High-quality hydrophobic filters block aerosol contamination

• Outstanding low-binding performance: Minimizes non-specific adsorption of proteins and nucleic acids

• High consistency: Strict quality control ensures low batch-to-batch variation

• Broad configurations: Wide volume range, multiple packaging options, sterile and non-sterile available.

Designed for Today’s Labs and Tomorrow’s Workflows

With these box structure upgrades and a comprehensive pipette tip portfolio, NEST continues to focus on practical innovation that improves everyday laboratory operations. The goal is simple: better usability, better organization, and consistent performance you can rely on.

NEST Completes FDA Establishment Registration: Strengthening Compliance and Advancing Global Market Access

NEST Scientific is proud to announce the successful completion of U.S. Food and Drug Administration (FDA) establishment registration and the receipt of its FDA registration certificate. 

This important milestone confirms that NEST has met the foundational regulatory requirements for entering the U.S. market for life science and biopharmaceutical–related products. It also reflects the company’s strong capabilities in compliance management, quality systems, and international operations—further reinforcing NEST’s position as a trusted global manufacturing partner.

What FDA Registration Means for NEST

FDA establishment registration represents a major step forward in NEST’s long-term commitment to standardized, globally aligned management practices.

By being officially recognized and listed in the FDA database, NEST achieves:

• International traceability of its corporate entity and operations

• Confirmation that its quality management system aligns with internationally recognized standards

• Validation that its research, development, and manufacturing processes meet global regulatory expectations

Together, these elements significantly strengthen NEST’s credibility in highly regulated markets such as North America and Europe, while supporting future regulatory pathways worldwide.

What This Means for Our Customers

For customers in pharmaceutical, biotechnology, clinical, and research markets, NEST’s FDA registration translates into tangible benefits:

Lower Compliance Risk
Clear regulatory standing simplifies audits, inspections, and supplier qualification processes.

More Stable Supply
FDA registration requires ongoing compliance maintenance, helping ensure consistent manufacturing controls, product quality, and long-term supply reliability.

Faster Global Expansion
FDA registration is often a critical prerequisite in international projects, reducing regulatory communication barriers and accelerating market entry.

Scope of FDA Registration and Product Listing

NEST’s FDA registration and product listing encompass multiple core product categories, including:

Laboratory and Clinical Consumables

• Cell culture products

• Sterile sample containers

• Centrifuge tubes

Cell and Microbiology Products

• Media preparation tools

• Transportation and storage solutions

Medical and Drug Delivery Components

• Injection Pens

• Sterile swabs and absorbent tips

• Nasal drug delivery devices

This broad coverage supports a wide range of applications across life science research, diagnostics, pharmaceutical manufacturing, and drug delivery.

Compliance as a Long-Term Commitment

While FDA registration represents a significant achievement, it is only one step in NEST’s ongoing globalization journey.

NEST remains committed to:

• Continuous regulatory compliance

• Ongoing quality system improvement

• Investment in advanced manufacturing and validation capabilities

By keeping compliance as a fundamental principle and product quality as its core focus, NEST will continue delivering stable, reliable, and trusted consumables and solutions to life science and biopharmaceutical customers worldwide.

NEST Scientific’s Quality Accreditations: Building Confidence in Drug-Device Manufacturing

In the development of drug-delivery systems and pharmaceutical packaging, quality is not a marketing claim—it is a regulatory requirement and a commercial necessity. For pharmaceutical, biotech, and combination-product developers, selecting a manufacturing partner with robust quality accreditations directly impacts patient safety, regulatory success, and long-term product performance.

NEST Scientific has established a comprehensive quality and compliance ecosystem that spans international certifications, cleanroom manufacturing, validated production processes, and rigorous performance testing. Together, these elements demonstrate NEST’s commitment to producing pen injectors, cartridges, and self-administration systems that meet the world’s most demanding regulatory expectations.

A Globally Recognized Quality Management System

At the foundation of NEST Scientific’s quality strategy is a certified quality management system aligned with internationally recognized standards.

NEST has obtained multiple authoritative certifications, including:

• ISO 9001 – Quality Management Systems

• ISO 13485 – Medical Device Quality Management Systems

• ISO 11137 – Sterilization of Health Care Products

• FDA Registration

• CE Marking

• Medical device licenses in multiple countries

These certifications confirm that NEST’s quality system governs product design, manufacturing, inspection, sterilization, and traceability under controlled, audited conditions

In addition, NEST production lines strictly follow GMP standards, supported by full-process third-party monitoring to ensure ongoing compliance.

Why this matters:
For pharmaceutical and biotech partners, these certifications reduce supplier qualification burden, streamline audits, and support faster regulatory submissions across global markets.

MDSAP Five-Country Certification

Many NEST pen injector platforms are supported by MDSAP (Medical Device Single Audit Program) five-country certification, covering:

• United States

• Canada

• Brazil

• Australia

• Japan

This single audit framework allows regulatory bodies in these regions to rely on one harmonized audit instead of separate country-specific inspections.

NEST products also carry multiple national registrations and licenses, including:

• USA 510(k) clearances

• Canada Medical Device Licenses

• China Class II Medical Device Certificates

• Indonesia, Malaysia, and Brazil medical device registrations

Examples include USA 510(k) numbers for multiple pen injector systems and China CDE registrations for TSA, SP, and automatic pen injector platforms

Why this matters:
MDSAP participation and country-specific approvals demonstrate NEST’s ability to meet diverse regulatory expectations simultaneously—an important advantage for globally launched drug products.

Certified Cleanroom Manufacturing Infrastructure

NEST operates multiple clean manufacturing environments designed for medical device and pharmaceutical packaging production:

• 10,600 m² Class 100,000 cleanshop

• 3,600 m² Class 10,000 cleanshop

• 2,300 m² Pen Injector Controlled Workshop

Injection molding, assembly, and packaging for pen injectors are performed within controlled cleanroom environments to minimize particulate and contamination risk.

For RTU cartridges, NEST employs advanced automated washing and assembly lines with local Class 100 environments, further strengthening contamination control.

Why this matters:
Cleanroom classification directly impacts bioburden control, particulate levels, and sterility assurance—critical factors for injectable drug-device combinations.

Sterilization Validation and SAL Assurance

NEST RTU cartridges support:

• Moist heat (steam) sterilization

• Sterility Assurance Level (SAL) = 10⁻⁶

These options allow customers to select sterilization approaches aligned with their drug formulation and regulatory strategy.

Why this matters:
Validated sterilization with documented SAL performance is essential for regulatory submissions and ensures consistent sterility across batches.

Compliance with ISO 11608 for Injection Systems

NEST performs product performance verification testing in accordance with:

• YY/T 1768.1-2021 (ISO 11608-1:2014, NEQ)

• YY/T 1768.2-2021 (ISO 11608-2:2014, NEQ)

These standards govern needle-based injection systems, including dose accuracy, injection force, leakage, mechanical strength, and lifecycle performance.

Key validated tests include:

• Injection start force

• Final dose accuracy

• Free-fall dose accuracy

• Dose accuracy under cold, standard, warm, dry heat, frozen, and humid conditions

• Vibration testing

• Lifecycle and cyclic testing

• Stability verification and accelerated aging

All tests reported meet applicable standards.

Why this matters:
Compliance with ISO 11608 demonstrates that NEST devices meet internationally accepted performance and safety benchmarks for pen injectors.

FTO (Freedom-to-Operate) and Patent Risk Mitigation

NEST reports completed FTO analysis covering:

• China

• United States

• United Kingdom

• Europe

Designs incorporate patent risk-mitigated structures to reduce intellectual property exposure for customers.

Why this matters:
FTO support lowers the risk of late-stage IP conflicts that can delay or derail commercialization.

Raw Material Compliance: ROHS & REACH

NEST enforces strict raw-material compliance and supplier qualification programs, including:

• Physical and chemical analysis of incoming materials

• Batch inspections and performance validation

• Supplier audits and documentation review

Raw materials used in reusable pen injectors comply with:

• ROHS (2011/65/EU)

• REACH (EC 1907/2006)

Materials include medical-grade ABS, PC, PP, and other polymers with supporting compliance documentation

Why this matters:
Material compliance is essential for regulatory filings and for minimizing toxicological risk in long-term injectable therapies.

Certified Measurement and Inspection Equipment

NEST’s quality labs utilize advanced metrology and inspection systems, including:

• ZEISS three-coordinate measuring systems

• Keyence IM series dimension scanners

• Industrial CT scanners

• Pharmaceutical packaging tear and peel strength testers

These systems support high-accuracy dimensional verification and mechanical performance testing.

Why this matters:
High-precision inspection ensures tight tolerances, consistent assembly, and reproducible device performance.

Batch Release, Periodic Monitoring & Closed-Loop Quality Management

NEST implements:

• Batch release tests

• Annual periodic monitoring per ISO 11608

• Appearance, labeling, torque, dose accuracy, and sensory feedback inspections

• Closed-loop quality management from testing → engineering review → project approval

The quality team is trained in core tools such as APQP and FMEA and operates under standardized certification systems.

Why this matters:
Ongoing monitoring ensures long-term consistency, not just initial validation success.

What NEST’s Accreditations Mean for Your Program

For pharmaceutical, biotech, and combination-product developers, NEST Scientific’s quality accreditations translate into:

•  Lower regulatory risk
•  Faster supplier qualification
•  Stronger audit outcomes
•  Reduced IP exposure
•  Reliable, repeatable device performance
•  Global commercialization readiness

Global commercialization readiness

Quality at NEST is not confined to certificates it is built into facilities, processes, validation, materials, and people.