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Downstream Purification in Kenya Engineering Excellence & Technical Support

Downstream Purification solutions for Bioprocessing & Manufacturing. High-standard technical execution following OEM protocols and local regulatory frameworks.

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Advanced Membrane Filtration for Potable Water

Implementing state-of-the-art microfiltration (MF) and ultrafiltration (UF) systems to remove suspended solids, bacteria, and viruses from raw water sources, ensuring safe and potable water for urban and peri-urban communities across Kenya.

Nanotechnology-Enhanced Adsorption for Contaminant Removal

Utilizing novel nanomaterials, such as functionalized activated carbon and zeolites, to efficiently adsorb and remove heavy metals, pesticides, and emerging contaminants from industrial wastewater and agricultural runoff, safeguarding water bodies.

Modular Activated Carbon Filtration for Diverse Industrial Effluents

Deploying modular and scalable activated carbon filtration units for the effective removal of organic pollutants, dyes, and chemical residues from various industrial wastewater streams, including textile, food processing, and chemical manufacturing sectors in Kenya.

What Is Downstream Purification In Kenya?

Downstream purification in Kenya refers to the series of separation and purification processes applied to a crude product, typically a biomolecule or a synthesized chemical, after its initial production or fermentation. The primary objective is to isolate the target molecule from a complex mixture of impurities such as host cell proteins, nucleic acids, lipids, salts, and other process-related contaminants. This stage is critical for achieving the required purity, yield, and quality for the intended application, be it pharmaceutical, diagnostic, industrial, or research use. The processes employed are highly dependent on the nature of the target product and the impurities present.

Who Needs Downstream Purification?Typical Use Cases in Kenya
Biopharmaceutical Companies: Producing therapeutic proteins (e.g., monoclonal antibodies, enzymes, vaccines), recombinant DNA products, and gene therapy vectors.Diagnostic Kit Manufacturers: Purifying antigens, antibodies, or nucleic acids for use in diagnostic assays (e.g., ELISA kits, PCR reagents).Research Institutions and Universities: Isolating and purifying biomolecules for fundamental research, drug discovery, and development.Agrochemical Companies: Producing purified active ingredients for pesticides and herbicides.Food and Beverage Industry: Extracting and purifying functional ingredients, enzymes, or flavor compounds.Specialty Chemical Manufacturers: Isolating high-purity chemical intermediates or final products.Water Treatment Facilities: Removing specific contaminants or concentrating valuable substances from wastewater or industrial effluents.
Production of Vaccines: Essential for isolating and purifying viral or bacterial antigens for vaccine formulations.Manufacturing of Monoclonal Antibodies (mAbs): Crucial for producing therapeutic mAbs for cancer treatment and other diseases.Development of Diagnostic Reagents: Ensuring the purity and specificity of components used in disease detection.Biotechnology Research: Enabling the study of purified proteins, nucleic acids, and other biological molecules.Industrial Enzyme Production: Isolating enzymes for use in sectors like detergents, food processing, and biofuels.Pharmaceutical Ingredient Manufacturing: Producing active pharmaceutical ingredients (APIs) with stringent purity requirements.Bioremediation and Environmental Monitoring: Isolating specific microorganisms or enzymes for pollution control or detection.

Key Aspects of Downstream Purification in Kenya

  • Objective: To isolate and purify a target molecule to a defined level of purity and quality.
  • Complexity: Involves multiple, often sequential, unit operations tailored to the specific product and impurity profile.
  • Validation: Requires rigorous validation to ensure reproducibility, scalability, and compliance with regulatory standards (e.g., for pharmaceuticals).
  • Cost: A significant contributor to the overall production cost, often representing 50-80% of the total manufacturing expenditure.
  • Scalability: Processes must be designed for scalability from laboratory to pilot and commercial manufacturing scales.

Who Needs Downstream Purification In Kenya?

In Kenya's burgeoning industrial and research landscape, the need for robust and efficient downstream purification processes is becoming increasingly critical. Downstream purification refers to the series of operations required to isolate and purify a target product from a complex mixture, often after a biological or chemical production process. This process is vital for ensuring product quality, safety, and efficacy, especially in sectors producing high-value compounds. The target customers for downstream purification services and technologies in Kenya span a diverse range of industries and research institutions, each with specific requirements and applications.

Customer SectorKey Departments/FunctionsSpecific Purification Needs
Pharmaceutical & BiopharmaceuticalManufacturing, Quality Control (QC), Research & Development (R&D), Process DevelopmentAntibody purification, Vaccine antigen purification, Recombinant protein isolation, Monoclonal antibody downstream processing, API (Active Pharmaceutical Ingredient) isolation and polishing.
Food & BeverageProduct Development, Quality Assurance (QA), Manufacturing, Food TechnologyEnzyme purification, Natural extract isolation, Vitamin and mineral fortification ingredient purification, High-purity flavor and fragrance compound extraction.
Agricultural BiotechnologyR&D, Product Development, ProductionBio-pesticide active ingredient purification, Bio-fertilizer component isolation, Plant-derived compound extraction, Animal vaccine antigen purification.
Chemical IndustryR&D, Process Engineering, Manufacturing, Quality ControlFine chemical synthesis purification, Catalyst precursor purification, Specialty polymer monomer isolation, High-purity solvent purification.
Academic & Research InstitutionsResearch Labs (various disciplines), Core Facilities, Analytical ServicesProtein purification for research, Nucleic acid purification, Biomarker isolation, Nanoparticle purification, Sample preparation for advanced analytics.
Diagnostics & Medical DevicesR&D, Manufacturing, Quality ControlDiagnostic reagent purification, Protein purification for assay development, Biocompatible material purification, Sterilization-grade purification of medical device components.
Environmental SectorR&D, Process Engineering, OperationsBiofuel component purification, Bioremediation agent isolation, Water purification for industrial use, Pollutant removal and recovery.

Key Target Customers and Departments in Kenya Requiring Downstream Purification

  • {"title":"Pharmaceutical and Biopharmaceutical Industry","description":"This is arguably the largest and most critical sector. Companies developing and manufacturing drugs, vaccines, antibodies, recombinant proteins, and other biotherapeutics rely heavily on downstream purification to achieve the stringent purity standards required for human and animal health."}
  • {"title":"Food and Beverage Industry","description":"Producers of specialized food ingredients, functional foods, natural extracts, enzymes for food processing, and high-purity ingredients for nutritional supplements often require sophisticated purification to remove impurities, enhance shelf-life, and meet regulatory standards."}
  • {"title":"Agricultural Biotechnology","description":"Companies involved in developing bio-pesticides, bio-fertilizers, genetically modified crop components, and animal health products need purification to isolate and standardize active ingredients and ensure their efficacy and safety."}
  • {"title":"Chemical Industry","description":"Manufacturers of fine chemicals, specialty chemicals, catalysts, and advanced materials often require high-purity intermediates or final products. This can include industries like petrochemicals, polymers, and materials science."}
  • {"title":"Academic and Research Institutions","description":"Universities and research centers conducting cutting-edge studies in areas like molecular biology, virology, proteomics, genomics, and materials science require downstream purification for sample preparation, method development, and validation of new discoveries."}
  • {"title":"Diagnostics and Medical Device Manufacturers","description":"Producers of diagnostic kits, reagents for medical testing, and components for medical devices (e.g., biocompatible materials, purified proteins for assays) need to ensure the purity and consistency of their products."}
  • {"title":"Environmental Sector","description":"Organizations involved in water treatment, waste remediation, and the production of biofuels or bio-based chemicals may require purification steps to isolate target compounds or remove pollutants."}

Downstream Purification Process In Kenya

This document outlines the typical workflow for a downstream purification process in Kenya, from the initial inquiry to the successful execution of the service. This encompasses a structured approach to ensure clarity, efficiency, and successful project completion.

StageDescriptionKey ActivitiesResponsible Parties
Inquiry & Initial ConsultationThe client initiates contact with the service provider, expressing their need for downstream purification services.Initial discussion of project scope, requirements, and objectives. Clarification of the purification process needed (e.g., water, chemicals, wastewater).Client, Service Provider (Sales/Technical Team)
Information Gathering & Site AssessmentDetailed understanding of the client's existing process, the feedstock to be purified, and the desired purity levels.Review of client's technical data. Site visit to assess existing infrastructure, potential challenges, and safety requirements. Sample collection for laboratory analysis.Service Provider (Technical Team), Client
Proposal Development & QuotationBased on the gathered information, a comprehensive proposal is drafted.Detailed technical solution, equipment specifications, methodology, timeline, cost breakdown, and terms and conditions.Service Provider (Technical & Commercial Teams)
Contract Negotiation & AgreementReview and discussion of the proposal and quotation by both parties.Negotiation of pricing, payment terms, delivery schedules, scope of work, and legal clauses. Formalization of the agreement through a signed contract.Client, Service Provider (Legal & Commercial Teams)
Project Planning & SchedulingDevelopment of a detailed project execution plan.Defining specific tasks, timelines, milestones, resource allocation, and contingency plans. Communication of the plan to the client.Service Provider (Project Manager), Client
Resource Allocation & MobilizationGathering and preparing all necessary resources for the project.Procurement of equipment, materials, and chemicals. Deployment of skilled personnel and specialized machinery to the client's site.Service Provider (Operations Team), Client (for site access and support)
On-site Execution & PurificationThe actual implementation of the downstream purification process.Installation of equipment, setting up of purification units, and commencement of the purification process as per the agreed methodology. Continuous monitoring of process parameters.Service Provider (On-site Team), Client (for operational liaison)
Quality Control & TestingEnsuring the purified output meets the specified quality standards.Regular sampling and laboratory analysis of the purified product. Verification of purity levels against client specifications and industry standards.Service Provider (QC Team), Client (for verification)
Documentation & ReportingComprehensive record-keeping and reporting of the purification process.Detailed logs of operations, test results, deviations, and recommendations. Submission of interim and final reports to the client.Service Provider (Project Manager/Technical Team)
Client Handover & FeedbackFormal transfer of the purified product and project completion documentation.Presentation of final report and results. Discussion of any observations or recommendations. Gathering client feedback on the service.Service Provider (Project Manager), Client
Invoicing & PaymentIssuance of the final invoice and processing of payment.Submission of the final invoice according to the contract terms. Client remits payment within the agreed timeframe.Service Provider (Finance Team), Client (Finance Department)
Post-Execution SupportProviding ongoing support and addressing any post-project queries.Troubleshooting, addressing warranty claims, and offering recommendations for future optimizations or maintenance.Service Provider (Technical Support/After-Sales Team)

Downstream Purification Process Workflow in Kenya

  • Inquiry & Initial Consultation
  • Information Gathering & Site Assessment
  • Proposal Development & Quotation
  • Contract Negotiation & Agreement
  • Project Planning & Scheduling
  • Resource Allocation & Mobilization
  • On-site Execution & Purification
  • Quality Control & Testing
  • Documentation & Reporting
  • Client Handover & Feedback
  • Invoicing & Payment
  • Post-Execution Support

Downstream Purification Cost In Kenya

The cost of downstream purification processes in Kenya can vary significantly depending on several key factors, impacting the overall pricing. These factors include the scale of operation (laboratory, pilot, or industrial), the specific purification techniques employed, the purity requirements of the final product, the source and nature of the raw material, and the geographical location within Kenya. Kenya's economic landscape and currency fluctuations (Kenyan Shilling - KES) also play a crucial role in determining the final cost.

Key Pricing Factors:

  • Purification Technology: Different techniques have vastly different capital and operational costs. For example, simple filtration is less expensive than chromatography or membrane filtration (e.g., ultrafiltration, nanofiltration). The complexity and sophistication of the chosen method are primary cost drivers.
  • Scale of Production: Larger-scale operations generally benefit from economies of scale, leading to lower per-unit purification costs. However, the initial capital investment for large-scale equipment is substantially higher.
  • Purity Requirements: Achieving higher purity levels often necessitates more rigorous and multi-step purification processes, increasing both time and resource consumption. The target application of the purified product (e.g., pharmaceutical grade vs. industrial grade) dictates the required purity.
  • Raw Material Characteristics: The initial quality and composition of the feedstock influence the purification process. Highly contaminated or complex raw materials will likely require more intensive and costly purification steps.
  • Consumables and Reagents: The cost of filters, membranes, chromatography resins, solvents, buffers, and other consumables used in the purification process contributes significantly to operational expenses.
  • Energy and Utilities: Purification processes can be energy-intensive (e.g., heating, cooling, pumping). The cost of electricity, water, and steam in Kenya directly impacts purification expenses.
  • Labor and Expertise: Skilled personnel are required to operate and maintain sophisticated purification equipment. Labor costs in Kenya, including salaries and training, are a factor.
  • Capital Investment (CAPEX): The initial purchase and installation of purification equipment represent a substantial upfront cost, which is often amortized over the lifespan of the equipment and factored into the overall pricing.
  • Operational Expenses (OPEX): Ongoing costs include maintenance, repairs, utilities, consumables, and labor.
  • Regulatory Compliance: For certain industries (e.g., pharmaceuticals, food and beverage), adherence to stringent regulatory standards may require specialized equipment, validation, and documentation, adding to the cost.
  • Location: While not as significant as other factors, accessibility and logistics for obtaining consumables and disposing of waste in more remote areas of Kenya might slightly influence costs.

Pricing Ranges in Kenyan Shillings (KES):

It is challenging to provide exact pricing without specific project details. However, we can outline potential ranges based on common purification needs in Kenya.

For illustrative purposes, consider the following:

  • Small-scale/Laboratory Purification (e.g., for research, pilot studies, or specialized small-batch production): This could range from KES 5,000 to KES 50,000+ per batch or per liter, depending on the complexity of the technique (e.g., basic filtration vs. preparative HPLC). The cost here is highly variable and often driven by the cost of consumables and the time of highly skilled personnel.
  • Medium-scale/Pilot Plant Purification (e.g., for process development, small commercial batches): This might fall in the range of KES 10,000 to KES 100,000+ per batch or per day of operation. Costs here are influenced by equipment rental/usage, higher volumes of consumables, and dedicated operational time.
  • Industrial-scale Purification (e.g., for large-scale manufacturing of chemicals, pharmaceuticals, or food products): These costs are typically calculated on a per-unit basis (e.g., per kilogram, per liter, or per cubic meter of treated material) and can range widely. For very large volumes and relatively simpler purification, it might be as low as KES 50 to KES 500 per unit. However, for highly demanding purity standards (e.g., biopharmaceuticals) requiring advanced techniques like large-scale chromatography, the cost could easily exceed KES 1,000 to KES 5,000+ per unit, or even more for extremely high-value products. The capital investment amortization is a significant component in these calculations.

Important Note: These figures are indicative and can fluctuate based on the current economic climate in Kenya, import duties on equipment and consumables, and specific supplier pricing. Engaging with local purification service providers or equipment suppliers is crucial for obtaining accurate and tailored quotes.

Scale of OperationEstimated Cost Range (KES)Notes
Small-scale/Laboratory5,000 - 50,000+ per batch/literHighly dependent on technique complexity, consumables, and skilled labor time.
Medium-scale/Pilot Plant10,000 - 100,000+ per batch/dayIncludes equipment usage, higher consumable volumes, and dedicated operational time.
Industrial-scale (Basic Purification)50 - 500 per unit (kg/liter/m³)For large volumes and relatively simpler purification processes.
Industrial-scale (Advanced/High Purity)1,000 - 5,000+ per unit (kg/liter/m³)For demanding purity standards (e.g., pharmaceuticals, bioprocessing) requiring complex technologies; can be significantly higher for specialized products.

Key Factors Influencing Downstream Purification Costs in Kenya

  • Scale of Operation (Laboratory, Pilot, Industrial)
  • Purification Technology Employed (Filtration, Chromatography, Membrane Separation, etc.)
  • Required Purity of the Final Product
  • Nature and Purity of the Raw Material
  • Cost of Consumables and Reagents (Filters, Resins, Solvents)
  • Energy and Utility Consumption (Electricity, Water, Steam)
  • Labor Costs and Expertise Required
  • Capital Investment (Equipment Purchase & Installation)
  • Operational Expenses (Maintenance, Repairs)
  • Regulatory Compliance and Validation Requirements
  • Geographical Location within Kenya
  • Market Demand and Supplier Pricing

Affordable Downstream Purification Options

Affordable downstream purification is a critical consideration for any bioprocess, directly impacting the cost-effectiveness and scalability of a product. Achieving high purity without exorbitant expense often involves a strategic combination of techniques and careful planning. This approach leverages "value bundles" – integrated sets of purification steps that are more efficient together than individually – and employs various cost-saving strategies to minimize resource utilization and capital expenditure.

Purification StepTypical ApplicationCost-Saving Benefit
Precipitation (Salt or pH-based)Initial capture/concentration, bulk impurity removalSignificant reduction in downstream volume, lower reagent cost compared to chromatography for bulk removal
Tangential Flow Filtration (TFF) / Ultrafiltration (UF)Concentration, buffer exchange, removal of small molecules/saltsHigh throughput for large volumes, reduces need for extensive chromatography for concentration
Ion Exchange Chromatography (IEC)Separation based on charge, removal of charged impuritiesCost-effective for specific charge-based separations, reusable resins
Size Exclusion Chromatography (SEC)Separation based on size, removal of aggregates/fragmentsCan be integrated for polishing, but can be slower and require larger columns for high throughput
Hydrophobic Interaction Chromatography (HIC)Separation based on hydrophobicityUseful for proteins with moderate hydrophobicity, can offer complementary selectivity to IEC
Affinity ChromatographyHighly specific capture using ligands (e.g., Protein A for antibodies)High purity in a single step, but ligand cost and potential for leaching can be significant; optimize loading and elution
Membrane ChromatographyHigh throughput, various separation modesLower pressure drop, faster flow rates, can be more scalable than packed-bed for some applications, disposable options available

Key Value Bundles and Cost-Saving Strategies

  • {"items":["Capture & Intermediate Purification (e.g., Precipitation + Chromatography): This bundle focuses on efficiently concentrating the target molecule from a complex mixture while removing bulk impurities. Precipitation, often using salts or pH adjustments, can significantly reduce downstream volume and complexity, making subsequent chromatographic steps more manageable and cost-effective.","Polishing & Fine Purification (e.g., Ion Exchange + Size Exclusion Chromatography): Once the bulk of impurities are removed, these steps target specific characteristics of the molecule (charge, size) to achieve final high purity. Using them in sequence optimizes the removal of closely related contaminants.","Filtration & Concentration (e.g., Tangential Flow Filtration (TFF) + Ultrafiltration (UF)): TFF and UF are highly effective for concentrating large volumes and removing smaller impurities. Bundling these can significantly reduce processing time and the need for more expensive chromatographic methods for initial concentration.","Membrane Chromatography Bundles: Modern membrane chromatography offers high throughput and can be configured for various separation modes (ion exchange, affinity, hydrophobic interaction). Bundling these with pre-filtration steps can be a cost-effective alternative to traditional packed-bed chromatography for certain applications."],"title":"Value Bundles: Integrated Purification Sequences"}
  • {"items":["Process Optimization: Thoroughly understanding the impurity profile and optimizing each purification step to maximize yield and purity with minimal reagent and buffer usage. This includes determining optimal loading capacities, flow rates, and buffer compositions.","Single-Use Technologies (SUTs): While initial capital costs might be higher for some SUT components, they eliminate the need for extensive cleaning and validation, reducing labor, water, and chemical costs, especially for smaller-scale or multi-product facilities. Consider SUT consumables in conjunction with reusable equipment.","Buffer Recycling and Reuse: Where feasible and validated for product quality, recycling and reusing buffers can significantly reduce consumption and waste disposal costs. This is particularly applicable for less sensitive purification steps or for buffer types that can be easily regenerated.","Minimizing Chromatography Resin Usage: Choosing resins with high binding capacity and optimizing loading conditions can reduce the amount of expensive chromatography resin required per batch. Consider resin lifetime and regeneration efficiency.","Alternative Separation Technologies: Exploring less expensive but effective alternatives to traditional chromatography, such as solid-phase extraction (SPE) for specific applications, or advanced precipitation techniques.","Scale-Up Considerations: Designing a purification strategy that scales efficiently. Often, initial scale-up might involve more robust and potentially less expensive methods, with finer purification steps introduced at later stages.","Automation and Process Control: Implementing automation can reduce labor costs, improve reproducibility, and allow for tighter control over process parameters, minimizing errors and rework. Smart sensors and real-time monitoring can also prevent costly failures.","Strategic Outsourcing: For specific, complex, or high-cost purification steps, outsourcing to Contract Manufacturing Organizations (CMOs) with specialized expertise and equipment can be more cost-effective than in-house development and operation."],"title":"Cost-Saving Strategies"}

Verified Providers In Kenya

In Kenya's evolving healthcare landscape, identifying reliable and high-quality healthcare providers is paramount. Franance Health has emerged as a leading force, distinguished by its rigorous credentialing process and commitment to excellence. This dedication ensures that their network comprises only the most competent and ethical healthcare professionals and facilities, offering unparalleled peace of mind to patients. Choosing a Franance Health-verified provider means opting for a higher standard of care, characterized by expertise, integrity, and a patient-centric approach.

Provider TypeFranance Health Verification BenefitsWhat Patients Can Expect
Hospitals & ClinicsEnsured adherence to international quality standards, advanced medical technology, and skilled medical staff.Access to state-of-the-art facilities, comprehensive treatment options, and a focus on patient outcomes.
Specialist DoctorsVerification of board certifications, specialized training, and proven track record in their respective fields.Expert diagnosis and treatment from highly qualified specialists with proven expertise.
General PractitionersConfirmation of valid medical licenses, continuous professional development, and a commitment to primary healthcare excellence.Reliable and accessible primary healthcare services, focusing on preventative care and effective management of common ailments.
Diagnostic LaboratoriesAccreditation by relevant bodies, use of validated testing methodologies, and accurate, timely results.Trustworthy and precise diagnostic reports crucial for accurate treatment planning.
PharmaciesVerification of dispensing licenses, proper drug storage and handling, and availability of genuine medication.Access to safe, authentic medications dispensed by qualified pharmacists.

Why Franance Health Credentials Matter

  • Rigorous Vetting: Franance Health employs a comprehensive evaluation process that scrutinizes the qualifications, experience, and ethical standing of every provider.
  • Quality Assurance: Verified providers adhere to strict quality benchmarks and best practices, ensuring consistent and effective patient care.
  • Patient Safety: The credentialing process prioritizes patient safety by ensuring providers meet stringent medical and operational standards.
  • Trust and Reliability: Franance Health verification acts as a mark of trust, enabling patients to make informed decisions with confidence.
  • Access to Excellence: Partnering with Franance Health grants access to a curated network of top-tier healthcare professionals and facilities across Kenya.

Scope Of Work For Downstream Purification

This Scope of Work (SOW) outlines the detailed requirements for the downstream purification of [Product Name/Biomolecule] produced from [Process Name/Source]. The objective is to achieve a highly pure and characterized final product meeting stringent quality standards for its intended application. This document specifies the technical deliverables, standard specifications, and key activities involved in the downstream purification process. It also includes a table summarizing key process steps and analytical requirements.

Process StepKey Equipment/MethodPrimary ObjectiveCritical Quality Attributes (CQAs)Standard Specifications
Cell Lysis/HarvestHomogenizer, Centrifuge, FiltrationRelease/Isolate [Product Name/Biomolecule]Product yield, Cell debris removal
= 95% cell lysis, < 5% residual cell debris
Primary CaptureAffinity Chromatography, Ion Exchange Chromatography, PrecipitationIsolate and concentrate the target productProduct recovery, Initial purity
= 80% recovery, >= 70% purity
Intermediate PurificationHydrophobic Interaction Chromatography (HIC), Size Exclusion Chromatography (SEC)Remove major impuritiesPurity, Removal of specific process-related impurities
= 90% purity, < 5% specific impurity X
Polishing StepIon Exchange Chromatography (IEX), SEC, Tangential Flow Filtration (TFF)Achieve final product purity and formulationFinal purity, Aggregates, Endotoxins, Host Cell Proteins (HCPs)
= 98% purity, < 2% aggregates, < 0.1 EU/mg, < 10 ppm HCPs
Concentration & FormulationTFF (Ultrafiltration/Diafiltration)Achieve target concentration and buffer exchangeProduct concentration, Buffer composition[Target Concentration] mg/mL, Specified buffer salts and pH
Sterile Filtration0.2 µm Sterile FilterEnsure product sterilitySterilitySterile (USP/EP/JP requirements)
Analytical CharacterizationHPLC, SDS-PAGE, ELISA, Mass Spectrometry, SpectrophotometryConfirm product identity, purity, and qualityIdentity, Purity, Potency, Impurities, endotoxins, etc.Refer to CoA for detailed specifications

Technical Deliverables

  • Purified [Product Name/Biomolecule] at specified concentration and purity levels.
  • Detailed batch records documenting all purification steps and analytical results.
  • Certificate of Analysis (CoA) for each purified batch, including all specified quality attributes.
  • Standard Operating Procedures (SOPs) for all purification and analytical methods.
  • Validation reports for all critical purification and analytical methods.
  • Raw material specifications and supplier qualification documentation.
  • Stability study data for the purified product.
  • Process flow diagrams and mass balance calculations.
  • Final report summarizing the entire purification campaign, including process performance and deviations.

Service Level Agreement For Downstream Purification

This Service Level Agreement (SLA) outlines the performance commitments and guarantees for the Downstream Purification services provided by [Your Company Name] to [Client Company Name]. It defines the expected response times for critical issues and the guaranteed uptime for the purification systems.

Service ComponentUptime GuaranteeResponse Time (Critical Issue)Resolution Target (Critical Issue)Response Time (Standard Issue)Resolution Target (Standard Issue)
Primary Purification System (e.g., Chromatography Skid)99.5% Uptime1 hour4 business hours4 business hours2 business days
Filtration Units (e.g., TFF, Depth Filtration)99.0% Uptime2 hours6 business hours8 business hours3 business days
Buffer Preparation and Delivery System99.5% Uptime1.5 hours5 business hours6 business hours2 business days
Process Control Software and Automation99.8% Uptime30 minutes3 business hours4 business hours1 business day
Ancillary Equipment (e.g., Pumps, Sensors)98.0% Uptime3 hours8 business hours12 business hours4 business days

Scope of Service

  • The Downstream Purification service encompasses the entire process of separating and purifying target biomolecules from complex mixtures, including but not limited to filtration, chromatography, and final polishing steps.
  • This SLA covers the operational availability and support responsiveness for the installed purification equipment and associated software as detailed in Appendix A.
  • Exclusions: This SLA does not cover scheduled maintenance, planned upgrades, or issues arising from user error or misuse of the equipment.
In-Depth Guidance

Frequently Asked Questions

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