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Sistemas de un solo uso y bioprocesamiento

Integrated Single-Use Fluid Paths for Flexible Bioprocessing
Preconfigured assemblies
Multiple vessel formats
Flexible fluid-path integration
Integrated Single-Use Fluid Paths for Flexible Bioprocessing

Productos destacados de bioprocesamiento de un solo uso

LAB SHOP NOW ofrece una gama completa de tecnologías de un solo uso diseñadas para mejorar la eficiencia del proceso, mantener la esterilidad y simplificar la gestión de fluidos en el bioprocesamiento ascendente y descendente. Nuestra cartera es compatible con laboratorios de investigación, plantas piloto, CDMO y plantas de fabricación biofarmacéutica comerciales con productos diseñados para un rendimiento constante y el cumplimiento de la normativa.

Sistemas de un solo uso y bioprocesamiento Sistemas de un solo uso y bioprocesamiento

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How to Choose the Right Single-Use System

Selecting the right single-use system requires careful consideration of process requirements, compatibility, sterility, scalability, and regulatory expectations. The following guide provides a structured approach to choosing the most suitable solution.

Step 1: Define Your Process Stage

Start by identifying where the product will be used within the manufacturing workflow.

Process Stage Recommended Products
Media Preparation Media Bags, Bottle Assemblies
Buffer Preparation Storage Bags, Bottle Assemblies
Cell Culture Single-Use Bags, Filters
Harvest Collection 2D & 3D Bags
Purification Capsule Filters, Tubing Assemblies
Sampling Sampling Systems
Fill-Finish Filling Needles, Bottle Assemblies

Step 2: Select the Right Product Configuration

Choose the configuration that best matches your workflow.

Tubing Assemblies

Designed for:

  • Fluid Transfer
  • Closed Systems
  • Bioreactor Connections
  • Sampling
  • Filling Operations

Custom Assemblies

Recommended when:

  • Standard products do not fit process requirements.
  • Specialized equipment connections are required.
  • Multiple components need to be integrated into one sterile assembly.

Bag Systems

Ideal for:

  • Media
  • Buffers
  • Storage
  • Mixing
  • Intermediate Product Collection

Bottle Assemblies

Best for:

  • Small Batch Processing
  • Sampling
  • Laboratory Scale Operations
  • Process Development

Step 3: Select the Appropriate Material

The material used in single-use components influences flexibility, durability, chemical compatibility, sterilization method, and overall process performance.

Common Materials

Material Typical Applications
Silicone Flexible tubing, fluid transfer
TPE (Thermoplastic Elastomer) Weldable tubing, sterile connections
EVA (Ethylene Vinyl Acetate) Single-use bioprocess bags
Polyethylene (PE) Fluid contact layers in bags and containers
Polypropylene (PP) Connectors, fittings, rigid components
Polycarbonate (PC) Bottle components, rigid housings
PTFE Chemically aggressive fluids and specialty applications

Material selection should consider chemical compatibility, temperature range, mechanical performance, sterilization method, and intended process use.

Step 4: Consider Sterility Requirements

Most single-use systems are supplied pre-sterilized to support aseptic processing and minimize contamination risk.

When evaluating products, consider:

  • Sterilization method (e.g., gamma irradiation)
  • Sterility assurance documentation
  • Packaging integrity
  • Shelf-life
  • Storage conditions

Step 5: Determine Connection Requirements

A successful fluid path depends on selecting compatible connection technologies.

Consider:

  • Tubing size
  • Connector style
  • Genderless or gendered systems
  • Flow rate requirements
  • Equipment compatibility
  • Ease of installation
  • Closed-system capability

Step 6: Evaluate Scalability

Choose products that support future scale-up.

Questions to consider:

  • Can the same technology be used from R&D through commercial manufacturing?
  • Are multiple bag sizes available?
  • Can assemblies be customized as production expands?
  • Are replacement components readily available?

Product Purchase Criteria

Selecting the right single-use products requires balancing process performance, quality, and regulatory expectations.

1. Sterility Assurance

Products intended for aseptic processing should be supplied with appropriate sterility validation and supporting documentation where applicable.

2. Material Compatibility

Ensure fluid-contact materials are compatible with the process fluids, operating temperatures, and sterilization methods used in your application.

3. Extractables & Leachables Profile

For biopharmaceutical manufacturing, understanding potential extractables and leachables is essential to evaluating product suitability and supporting risk assessments.

4. Tubing Compatibility

Verify:

  • Inner diameter
  • Wall thickness
  • Flexibility
  • Pressure rating
  • Weldability (if applicable)

5. Connector Compatibility

Confirm compatibility with:

  • Existing equipment
  • Tubing sizes
  • Flow requirements
  • Aseptic connection methods

6. Total Cost of Ownership

While single-use systems reduce cleaning, validation, and maintenance costs, procurement decisions should also consider product performance, process efficiency, and lifecycle costs—not just unit price.

7. Scalability

Choose systems that can support development through commercial manufacturing without requiring major redesigns.

8. Ease of Integration

Evaluate how easily the product integrates into existing equipment, process skids, and manufacturing workflows.

9. Supply Chain Reliability

Reliable product availability and consistent manufacturing are critical for maintaining production schedules and minimizing supply disruptions.

10. Validation Documentation

Depending on your quality system and application, consider products supported by documentation such as:

  • Certificates of Conformance
  • Lot Traceability
  • Material Specifications
  • Sterility Validation
  • Quality Certifications

Single-Use Product Selection Guide

Process Need Recommended Solution
Media Storage Single-Use Media Bags
Buffer Preparation Bottle Assemblies
Fluid Transfer Tubing Assemblies
Closed-System Connection Sterile Connectors
Sterile Filtration Capsule Filters
Aseptic Sampling Sampling Systems
Filling Operations Filling Needles
Custom Process Integration Custom Single-Use Assemblies

Expert Tip

Choose single-use systems based on your complete process—not individual components. A well-designed assembly with compatible bags, tubing, connectors, filters, and documentation can simplify validation, reduce contamination risks, improve operator efficiency, and support seamless scale-up from development to commercial manufacturing.

Common Challenges & Best Practices

Single-use systems have transformed modern bioprocessing by improving flexibility, reducing cleaning requirements, and supporting closed-system manufacturing. However, achieving consistent performance requires careful product selection, proper handling, and a well-designed process.

The following best practices can help reduce operational risks, maintain product quality, and improve manufacturing efficiency.

Challenge 1: Maintaining a Closed System

Every connection point introduces potential contamination risk. Poorly designed fluid paths or incompatible connectors can compromise sterility.

Best Practice

  • Use validated sterile connectors and disconnectors.
  • Minimize unnecessary connection points.
  • Standardize connection technologies across the process where possible.
  • Train operators on aseptic connection procedures.

Challenge 2: Selecting the Wrong Bag Configuration

Choosing the wrong bag size, port arrangement, or geometry can affect mixing efficiency, handling, and process integration.

Best Practice

Evaluate:

  • Required working volume
  • Headspace requirements
  • Mixing method
  • Number and type of ports
  • Integration with existing equipment
  • Storage and transport requirements

Challenge 3: Tubing Material Incompatibility

Different tubing materials offer varying levels of flexibility, weldability, pressure resistance, and chemical compatibility.

Best Practice

Select tubing based on:

  • Process fluid compatibility
  • Pump compatibility
  • Temperature requirements
  • Sterilization method
  • Required flexibility
  • Mechanical durability

Challenge 4: Managing Extractables & Leachables

Materials used in single-use systems may release trace compounds under certain processing conditions. Understanding these interactions is an important part of process risk assessment.

Best Practice

  • Review supplier documentation.
  • Perform application-specific risk assessments.
  • Consider process conditions such as temperature, pH, and solvent exposure.
  • Work with qualified suppliers that provide relevant supporting data.

Challenge 5: Scale-Up Challenges

A solution that performs well in laboratory-scale development may not directly translate to pilot or commercial manufacturing.

Best Practice

Select product families that are available in multiple sizes and configurations to support process development through commercial production while minimizing redesign.

Challenge 6: Documentation Gaps

Incomplete documentation can delay validation, quality reviews, and regulatory submissions.

Best Practice

Maintain organized documentation for:

  • Certificates of Conformance
  • Lot Traceability
  • Material Specifications
  • Sterility Documentation
  • Product Drawings
  • Validation Support Documents

Challenge 7: Supply Chain Continuity

Unexpected supply disruptions can affect manufacturing schedules and inventory planning.

Best Practice

  • Standardize on qualified product families where possible.
  • Forecast demand for critical consumables.
  • Maintain appropriate safety stock.
  • Partner with suppliers that offer dependable manufacturing and distribution capabilities.

Challenge 8: Operator Training

Even well-designed single-use systems can underperform if operators are unfamiliar with installation, handling, or connection procedures.

Best Practice

  • Develop standardized operating procedures (SOPs).
  • Provide routine operator training.
  • Use clearly labeled assemblies.
  • Verify connections before initiating fluid transfer.

Shop by Bioprocess Application

LAB SHOP NOW organizes laboratory plasticware by scientific workflow, making it easier to find products that match your application rather than simply browsing by product type.

Media & Buffer Preparation

Prepare, store, and transfer media and buffers using sterile, ready-to-use systems that reduce preparation time and contamination risks.

Recommended Products

  • Media Bags
  • Buffer Bags
  • Bottle Assemblies
  • Capsule Filters
  • Tubing Assemblies

Upstream Processing

Support cell culture and fermentation with products designed for sterile media handling, sampling, and fluid transfer.

Recommended Products

  • Single-Use Bags
  • Bottle Assemblies
  • Tubing Assemblies
  • Sterile Connectors
  • Sampling Systems

Downstream Processing

Enable efficient purification, clarification, and intermediate product handling with integrated disposable fluid paths.

Recommended Products

  • Capsule Filters
  • Tubing Assemblies
  • Storage Bags
  • Manifolds
  • Sterile Connectors

Fill-Finish Operations

Maintain product integrity during final filling and transfer operations using sterile, validated components.

Recommended Products

  • Filling Needles
  • Bottle Assemblies
  • Transfer Tubing
  • Sterile Connectors

Cell & Gene Therapy

Closed-system processing is critical for protecting high-value cell-based therapies and minimizing contamination.

Recommended Products

  • Closed-System Tubing Assemblies
  • Sampling Systems
  • Sterile Connectors
  • Transfer Bags
  • Cryogenic Storage Solutions

Vaccine Manufacturing

Support high-throughput vaccine production with scalable disposable technologies designed for sterile processing.

Recommended Products

  • Media Bags
  • Buffer Bags
  • Capsule Filters
  • Tubing Assemblies
  • Bottle Assemblies

Monoclonal Antibody Production

Single-use technologies simplify media preparation, fluid transfer, and sampling throughout mAb manufacturing.

Recommended Products

  • Storage Bags
  • Tubing Assemblies
  • Capsule Filters
  • Bottle Assemblies
  • Custom Fluid Paths

Process Development & Pilot Plants

Flexible, scalable systems allow rapid process optimization while reducing cleaning and changeover requirements.

Recommended Products

  • Bottle Assemblies
  • Small-Volume Bags
  • Sampling Systems
  • Capsule Filters
  • Custom Assemblies

Featured Brands

LAB SHOP NOW partners with globally recognized manufacturers of single-use technologies to provide reliable products for research, process development, and commercial biopharmaceutical manufacturing.

Available Brands

Why Buy Single-Use Systems from LAB SHOP NOW?

Technical Expertise Beyond Product Supply

Our team understands the challenges of biopharmaceutical manufacturing and provides guidance on selecting products that align with your process, quality requirements, and production goals.

Custom Assembly Support

Many manufacturing processes require assemblies tailored to unique equipment and workflows. LAB SHOP NOW supports custom configurations to simplify installation and reduce assembly time.

Documentation for Quality Systems

Products are available with supporting documentation, where applicable, to assist with qualification, validation, and quality management activities.

Reliable Supply & Fast Delivery

Our supply network is designed to help laboratories and manufacturing facilities maintain continuity for critical consumables and reduce procurement delays.

Regulatory & Quality Considerations

Single-use systems are frequently used in regulated biopharmaceutical environments where quality documentation and traceability are essential.

When evaluating products, consider:

  • Manufacturing quality systems
  • Lot traceability
  • Material specifications
  • Sterility documentation
  • Product labeling
  • Certificates of Conformance
  • Validation support documentation
  • Change notification policies

Always ensure that selected components align with your organization's quality procedures and regulatory requirements.

Sustainability Benefits of Single-Use Technology

Although single-use products generate disposable waste, they can also contribute to overall process sustainability by reducing resource consumption.

Potential benefits include:

  • Reduced water usage by eliminating routine cleaning
  • Lower consumption of cleaning chemicals
  • Reduced energy required for cleaning and sterilization
  • Smaller equipment footprint
  • Improved facility flexibility
  • Faster product changeovers that reduce production downtime

Organizations should evaluate sustainability across the entire product lifecycle, including manufacturing, transportation, use, and responsible disposal.

Comprehensive Product Portfolio

Source everything you need for your fluid path from a single supplier, including:

  • Bioprocess Bags
  • Bottle Assemblies
  • Tubing Assemblies
  • Connectors
  • Capsule Filters
  • Sampling Systems
  • Filling Needles
  • Custom Assemblies

Technical Services & Custom Assembly Support

Selecting the right single-use system often involves more than choosing individual components. Our specialists can help evaluate your application and recommend products that fit your process requirements.

We can assist with:

  • Product Selection Guidance
  • Fluid Path Design Support
  • Custom Assembly Recommendations
  • Component Compatibility
  • Process Scale-Up Planning
  • Documentation Requests
  • Bulk Procurement
  • Project-Based Sourcing

Related Categories

Build a complete bioprocess workflow with complementary product categories available at LAB SHOP NOW:

  • Filtration Products
  • Laboratory Plasticware
  • Glassware
  • Tubing & Connectors
  • Caps, Closures & Stoppers
  • Sample Storage & Cold Chain
  • Liquid Handling
  • Laboratory Safety & PPE
  • Stainless Steel & Hardware
  • Equipment & Small Instruments

Frequently Asked Questions Frequently Asked Questions

Los sistemas de un solo uso (SUS) son componentes desechables y preensamblados que se utilizan en la fabricación biofarmacéutica para la manipulación, el almacenamiento, la filtración, el muestreo y la transferencia de fluidos. Sustituyen a muchos sistemas tradicionales de acero inoxidable, lo que ayuda a reducir los requisitos de limpieza, minimizar el riesgo de contaminación cruzada y aumentar la flexibilidad de fabricación.

Las ventajas clave incluyen:

  • Riesgo reducido de contaminación cruzada
  • Eliminación de la validación de limpieza
  • Cambios de producto más rápidos
  • Menor consumo de agua y energía
  • Inversión de capital reducida
  • Mayor flexibilidad de fabricación
  • Menor tiempo de respuesta de las instalaciones
  • Simplificación de la ampliación y transferencia de tecnología

Una cartera típica de productos de un solo uso incluye:

  • Bolsas de bioproceso
  • Conjuntos de botellas
  • Conjuntos de tubos
  • Conectores estériles
  • Desconectores asépticos
  • Filtros de cápsula
  • Agujas de llenado
  • Sistemas de muestreo
  • Colectores
  • Conjuntos personalizados de un solo uso

Las bolsas de un solo uso se utilizan para:

  • Preparación de medios
  • Almacenamiento de tampones
  • Cultivo celular
  • Recolección de la cosecha
  • Almacenamiento intermedio de productos
  • Transferencia de sustancia farmacéutica a granel
  • Mezclado
  • Muestreo
  • Aplicaciones de congelación y descongelación

Las bolsas 2D son planas cuando se llenan y se utilizan comúnmente para el almacenamiento, el muestreo y el transporte.

Las bolsas 3D se expanden a una forma tridimensional y se utilizan típicamente en aplicaciones de mayor volumen que requieren mezcla, procesamiento o integración con contenedores de soporte.

Los conectores estériles permiten conectar las vías de fluido sin exponer el proceso al entorno externo. Apoyan la fabricación en sistemas cerrados y ayudan a mantener las condiciones asépticas durante toda la producción.

Los materiales comunes incluyen:

  • Silicona
  • Elastómero termoplástico (TPE)
  • Acetato de etileno-vinilo (EVA)
  • Polietileno (PE)
  • Polipropileno (PP)
  • Policarbonato (PC)
  • PTFE

Cada material se selecciona en función de su flexibilidad, compatibilidad química, método de esterilización y aplicación prevista.

Los extractables son compuestos que pueden liberarse de los materiales en condiciones de laboratorio agresivas, mientras que los lixiviables son compuestos que migran al producto en condiciones de proceso normales. La evaluación de estas características ayuda a los fabricantes a realizar evaluaciones de riesgo específicas del producto y a cumplir con las normativas.
Sí. Muchos fabricantes ofrecen conjuntos diseñados a medida que integran bolsas, tubos, conectores, filtros, colectores y componentes de muestreo en una única solución lista para usar, diseñada para requisitos de proceso específicos.
Muchos sistemas de un solo uso están diseñados para su uso en entornos de fabricación cGMP y están respaldados por documentación de calidad como trazabilidad de lotes, Certificados de Conformidad, validación de esterilidad y especificaciones de materiales. Los usuarios siempre deben verificar que el producto seleccionado cumpla con los requisitos de calidad y regulatorios de su organización.

Considere:

  • Compatibilidad de fluidos
  • Rango de temperatura
  • Flexibilidad
  • Requisitos de presión
  • Compatibilidad con la bomba
  • Método de esterilización
  • Requisitos de soldabilidad o sellado
  • Tipo de conexión

Dependiendo de su aplicación, puede solicitar:

  • Certificado de Conformidad (CoC)
  • Especificaciones del material
  • Información de trazabilidad del lote
  • Documentación de esterilidad
  • Documentos de soporte de validación
  • Dibujos del producto
  • Declaraciones reglamentarias (cuando corresponda)

Las tecnologías de un solo uso se utilizan ampliamente en:

  • Fabricación biofarmacéutica
  • Biotecnología
  • Producción de vacunas
  • Terapia celular
  • Terapia génica
  • Producción de anticuerpos monoclonales
  • CDMOs
  • Investigación académica
  • Laboratorios de desarrollo de procesos
Al eliminar la limpieza de equipos, reducir el tiempo de configuración, simplificar los cambios de producto y permitir la fabricación modular, los sistemas de un solo uso ayudan a las instalaciones a mejorar la productividad, reducir el tiempo de inactividad y acelerar los cronogramas de producción.

LAB SHOP NOW ofrece:

  • Marcas globales de confianza
  • Carteras completas de un solo uso
  • Orientación técnica sobre productos
  • Soporte para ensamblajes personalizados
  • Documentación detallada del producto
  • Precios competitivos
  • Entrega rápida en EE. UU.
  • Asistencia experta para la selección y el suministro de productos
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