Verified Service Provider in Zambia
Upstream Bioprocessing in Zambia
Engineering Excellence & Technical Support
Upstream Bioprocessing solutions for Bioprocessing & Manufacturing. High-standard technical execution following OEM protocols and local regulatory frameworks.
Scaling Up Biocatalyst Production
Pioneering the optimization and scale-up of microbial fermentation processes for the production of enzymes and bioactive compounds, crucial for Zambia's emerging bio-pharmaceutical and industrial biotechnology sectors. This involves advanced bioreactor design and continuous process monitoring to ensure high yields and consistent quality, reducing reliance on imported solutions.
Sustainable Bioremediation Solutions
Developing and implementing cost-effective upstream bioprocessing techniques for the efficient bioremediation of industrial and agricultural wastewater in Zambia. This focuses on harnessing specific microbial consortia and optimizing their growth conditions to break down pollutants, thereby safeguarding water resources and promoting environmental sustainability.
Biomass Valorization for Biofuels
Leveraging advanced upstream bioprocessing to efficiently convert abundant Zambian agricultural residues (e.g., maize stover, bagasse) into fermentable sugars. This forms the critical first step for subsequent downstream conversion into biofuels, offering a sustainable and domestically sourced energy alternative.
What Is Upstream Bioprocessing In Zambia?
Upstream bioprocessing in Zambia refers to the initial stages of producing biological products, encompassing the cultivation of microorganisms or cells and the production of the desired biomolecule. This service is critical for the development and manufacturing of biopharmaceuticals, biofuels, industrial enzymes, and other bio-based products. It typically involves three primary phases: strain development/selection, media preparation, and fermentation/cell culture. Strain development focuses on identifying or engineering high-yielding microbial strains or cell lines. Media preparation involves the precise formulation and sterilization of nutrient-rich environments to support optimal growth and product formation. Fermentation or cell culture is the core stage where the selected microorganisms or cells are cultured under controlled conditions (temperature, pH, dissolved oxygen, agitation) in bioreactors to produce the target product.
| Who Needs Upstream Bioprocessing? | Typical Use Cases in Zambia |
|---|---|
| Biotechnology Companies | Production of recombinant proteins (e.g., insulin, growth hormones) for pharmaceutical applications. |
| Agricultural Sector | Development and production of biofertilizers and biopesticides to enhance crop yields and reduce reliance on chemical inputs. |
| Food and Beverage Industry | Manufacturing of enzymes for food processing (e.g., baking, brewing), probiotics, and starter cultures for dairy products. |
| Research Institutions and Universities | Enabling fundamental research in molecular biology, genetic engineering, and microbial physiology; scaling up for pilot studies. |
| Renewable Energy Sector | Production of biofuels (e.g., ethanol, biogas) through the fermentation of biomass. |
| Water Treatment Facilities | Cultivation of specialized microorganisms for bioremediation and wastewater treatment. |
Key Components of Upstream Bioprocessing
- Strain Development and Optimization
- Media Formulation and Sterilization
- Bioreactor Design and Operation
- Process Monitoring and Control
- Cell Harvesting (if applicable before downstream)
Who Needs Upstream Bioprocessing In Zambia?
Upstream bioprocessing, the initial stage of producing biological products, is crucial for various sectors in Zambia. It involves the cultivation of living cells or microorganisms to produce the desired biomolecule or product. Understanding who needs this technology in Zambia is key to fostering innovation and economic growth in its burgeoning life sciences and agricultural industries.
| Customer Type | Specific Departments/Units | Needs & Applications |
|---|---|---|
| Pharmaceutical & Biotech Companies | Research & Development (R&D), Process Development, Manufacturing | Production of therapeutic proteins (e.g., insulin, antibodies), vaccines, gene therapies, diagnostic reagents, cell-based therapies. |
| Agricultural Research Institutions | Plant Breeding, Crop Protection, Soil Science, Animal Science | Development of biofertilizers, biopesticides, genetically modified crops (for enhanced traits), animal vaccines, probiotics for livestock. |
| Food & Beverage Industry | Product Development, Quality Control, Production | Production of industrial enzymes (e.g., for brewing, baking, detergent), starter cultures for dairy and fermented foods, probiotics for functional foods, production of biofuels. |
| Veterinary Medicine Sector | Vaccine Production, Diagnostic Kit Development, Animal Health Research | Manufacturing of animal vaccines, diagnostic antigens, antimicrobial agents, growth promoters. |
| Environmental Management Agencies | Environmental Remediation, Waste Treatment, Biotechnology Research | Development of microbial consortia for oil spill cleanup, wastewater treatment, bioremediation of contaminated sites. |
| Academic & Research Institutions | Biology Departments, Biochemistry Departments, Biotechnology Centers, Medical Schools | Culturing of cell lines for research, production of recombinant proteins for studies, fermentation for producing novel compounds, training future bioprocessing professionals. |
| Government Agencies | Ministry of Health, Ministry of Agriculture, Ministry of Science and Technology, National Biosafety Authority | Supporting national vaccine manufacturing capacity, improving food security through agricultural biotechnology, fostering a local biotechnology ecosystem, ensuring biosafety and biosecurity. |
Target Customers for Upstream Bioprocessing in Zambia
- Pharmaceutical and Biotechnology Companies: Developing novel therapeutics, vaccines, and diagnostic tools.
- Agricultural Research Institutions: Enhancing crop yields, developing disease-resistant varieties, and producing biopesticides.
- Food and Beverage Industry: Producing enzymes, probiotics, fermented products, and flavor enhancers.
- Veterinary Medicine Sector: Manufacturing animal vaccines, diagnostics, and growth promoters.
- Environmental Management Agencies: Developing bioremediation solutions for pollution control and waste management.
- Academic and Research Institutions: Conducting fundamental research in life sciences and biotechnology, requiring cell culture and fermentation facilities.
- Government Agencies: Supporting national health initiatives, food security programs, and industrial development.
Upstream Bioprocessing Process In Zambia
Upstream bioprocessing in Zambia, as in other regions, involves the initial stages of biotechnology production where biological raw materials are cultured and manipulated to produce desired biomolecules. This workflow, from the initial inquiry to the final execution, typically follows a structured, multi-stage process.
| Stage | Key Activities | Responsible Parties (Examples) | Key Deliverables/Outcomes | Considerations for Zambia |
|---|---|---|---|---|
| 1. Inquiry & Consultation | Initial contact from potential client/researcher/company. Discussion of project needs, objectives, target biomolecule, desired scale, and timeline. | Client/Researcher, Business Development Manager, Technical Lead | Understanding of project scope, preliminary needs assessment, initial proposal outline. | Local knowledge of available expertise and resources. Understanding of the Zambian market for bioprocessed products. |
| 2. Feasibility & Scoping | Detailed assessment of technical and economic viability. Literature review, preliminary experimental design, identification of required materials and equipment, regulatory pathway assessment, cost estimation. | R&D Scientists, Process Engineers, Business Analysts, Regulatory Affairs Specialists | Feasibility report, detailed project plan, preliminary budget, risk assessment, identified regulatory requirements. | Availability of specific cell lines, media components, and consumables in Zambia. Local regulatory body requirements (e.g., ZABS, Ministry of Health). |
| 3. Process Development & Optimization | Laboratory-scale experimentation to establish and optimize critical process parameters (e.g., media composition, temperature, pH, aeration, inoculation density). Strain improvement, if necessary. | R&D Scientists, Microbiologists, Cell Biologists, Biochemists | Optimized growth and production protocols, yield data, process understanding, preliminary specifications for downstream processing. | Access to well-equipped university or research labs. Collaboration with local academic institutions for specialized expertise. |
| 4. Technology Transfer & Scale-Up Planning | Transfer of developed process from lab scale to pilot or commercial scale. Detailed engineering design, equipment specification, validation strategies, Standard Operating Procedures (SOPs) development. | Process Engineers, Chemical Engineers, Quality Assurance (QA) Personnel | Scale-up strategy, equipment specifications, pilot plant design, draft SOPs, validation master plan. | Availability of skilled engineers and technicians. Sourcing of reliable equipment suppliers and maintenance services. |
| 5. Procurement & Infrastructure Setup | Acquisition of necessary raw materials, consumables, and equipment. Construction or modification of production facilities, installation of equipment, qualification and validation of utilities. | Procurement Department, Project Managers, Facilities Engineers, Validation Engineers | Procured materials and equipment, commissioned production facility, validated infrastructure. | Importation logistics for specialized equipment and consumables. Local sourcing opportunities for common materials. Power and water reliability. |
| 6. Execution & Production | Actual implementation of the upstream process according to established SOPs. Inoculation, cultivation, monitoring of growth and product formation, harvest. | Production Operators, Production Supervisors, QA/QC Personnel | Biomass/product generated, in-process data, batch records. | Trained local workforce. Strict adherence to biosafety and biosecurity protocols. Managing supply chain for ongoing consumables. |
| 7. Quality Control & Release | In-process and final product testing to ensure it meets predefined specifications. Verification of identity, purity, potency, and safety. | Quality Control (QC) Analysts, QA Officers | Analytical test results, Certificates of Analysis (CoAs), batch release decisions. | Access to accredited analytical laboratories. Training of QC personnel in relevant techniques. Ensuring compliance with international quality standards (e.g., GMP if applicable). |
| 8. Post-Production Analysis & Reporting | Data analysis, process performance evaluation, troubleshooting, and documentation. Reporting of results to the client. Recommendations for future improvements. | R&D Scientists, Process Engineers, Project Managers | Final project report, process performance metrics, recommendations for optimization or future production. | Knowledge transfer to local teams. Building capacity for continuous improvement in bioprocessing within Zambia. |
Upstream Bioprocessing Workflow in Zambia: Inquiry to Execution
- Phase 1: Inquiry and Initial Consultation
- Phase 2: Feasibility and Project Scoping
- Phase 3: Process Development and Optimization
- Phase 4: Technology Transfer and Scale-Up Planning
- Phase 5: Procurement and Infrastructure Setup
- Phase 6: Execution and Production
- Phase 7: Quality Control and Release
- Phase 8: Post-Production Analysis and Reporting
Upstream Bioprocessing Cost In Zambia
Upstream bioprocessing, encompassing stages like cell culture, media preparation, and inoculum development, plays a critical role in the overall cost of biopharmaceutical production in Zambia. Several factors significantly influence these costs, leading to a range of potential expenditures. Local currency pricing is influenced by import duties on specialized equipment and raw materials, availability of skilled labor, energy costs, regulatory compliance, and economies of scale. The choice of bioprocess (e.g., microbial fermentation vs. mammalian cell culture) and the complexity of the product also heavily dictate costs.
| Upstream Bioprocessing Stage/Component | Estimated Price Range (ZMW) | Notes |
|---|---|---|
| Cell Culture Media (per liter, complex formulations) | 500 - 2,000+ | Highly dependent on imported ingredients, growth factors, and specific formulations. Basic media may be less. |
| Single-Use Bioreactor Bag (e.g., 50L) | 10,000 - 30,000+ | Varies by size, manufacturer, and features. Essential for mammalian cell culture and reducing cleaning validation. |
| Small Scale Bioreactor System (e.g., 10L benchtop) | 150,000 - 500,000+ | Initial capital cost. Includes bioreactor vessel, controls, sensors. Excludes installation and validation. |
| Sterile Filtration (per unit, for media or buffers) | 50 - 200+ | Dependent on pore size, volume, and brand. For smaller volumes. |
| Skilled Biotechnologist (monthly salary) | 8,000 - 25,000+ | Varies based on experience, qualifications, and employer (research institution vs. commercial production). |
| Electricity (estimated monthly for a small lab) | 2,000 - 10,000+ | Highly variable based on equipment usage, energy efficiency, and prevailing tariffs. |
| Basic In-Process Testing Reagents (e.g., for cell counting) | 1,000 - 5,000+ (per month) | Depends on frequency of testing and specific assay kits. |
| Quality Control Testing (per batch analysis) | 5,000 - 50,000+ | Covers various tests like purity, potency, sterility. Complex analyses will be higher. |
Key Pricing Factors for Upstream Bioprocessing in Zambia
- Raw Material Costs: This includes media components (sugars, amino acids, salts, growth factors), buffers, and cleaning agents. The price volatility of imported components is a major factor. Local sourcing opportunities, where available, can offer cost advantages.
- Equipment and Infrastructure: Initial capital investment for bioreactors, centrifuges, incubators, laminar flow hoods, and associated utilities. Maintenance and calibration costs are ongoing expenses. The availability and cost of suitable facilities are also significant.
- Labor Costs: Salaries for skilled biotechnologists, cell culture technicians, engineers, and quality control personnel. The availability of a trained workforce in Zambia can impact overall personnel expenses.
- Energy Costs: Electricity consumption for incubators, bioreactors, HVAC systems, and other equipment. The reliability and pricing of electricity in Zambia can be a substantial cost driver.
- Consumables: Disposable items like filters, tubing, single-use bioreactor bags, and gloves. These can represent a significant recurring cost, especially in smaller-scale operations or for highly sensitive processes.
- Quality Control and Assurance: Costs associated with in-process testing, raw material testing, and final product characterization to meet regulatory standards. This includes reagents, equipment, and personnel time.
- Regulatory Compliance: Fees associated with obtaining permits, licenses, and adhering to Good Manufacturing Practices (GMP) or other relevant quality standards. This can involve audits and documentation preparation.
- Scale of Operation: Larger-scale bioprocessing generally benefits from economies of scale, leading to lower per-unit costs. Smaller, pilot-scale operations will invariably have higher costs per unit.
- Process Complexity and Yield: Highly specialized cell lines, complex media formulations, or processes with inherently lower yields will result in higher costs due to increased material consumption and longer processing times.
- Import Duties and Taxes: A significant contributor to the cost of imported equipment, reagents, and specialized consumables. Fluctuations in exchange rates also impact these costs.
Affordable Upstream Bioprocessing Options
Affordable upstream bioprocessing is crucial for the economic viability of biopharmaceutical production, especially for emerging therapies and smaller-scale manufacturing. This involves optimizing every stage from cell culture to harvesting to minimize costs without compromising product quality or yield. Key strategies revolve around strategic sourcing, process intensification, technology adoption, and efficient resource management. Understanding and implementing value bundles and cost-saving strategies can significantly reduce overall operational expenses.
| Value Bundle Type | Description | Cost-Saving Impact | Considerations |
|---|---|---|---|
| Optimized Media & Feed Strategies | Bundles of pre-tested, cost-effective media formulations and feeding regimes designed for specific cell lines and product targets. May include single-source or multi-source options with negotiated pricing. | Reduces raw material costs, improves cell growth and productivity (higher titers), minimizes media preparation time and labor. | Requires thorough process development and validation. Compatibility with existing equipment is essential. May involve commitment to specific suppliers. |
| Integrated Single-Use System Packages | Bundles of interconnected single-use bioreactors, tubing, connectors, and sensors designed for specific workflows (e.g., cell expansion, small-scale production). Often includes installation and validation support. | Reduces capital expenditure on stainless steel equipment, eliminates cleaning and sterilization validation costs, speeds up process implementation, minimizes cross-contamination risks. | Higher per-use consumable costs compared to reusable systems. Waste disposal considerations are important. Lot-to-lot variability needs careful monitoring. |
| Process Intensification Kit | A package of advanced sensor technologies (e.g., dissolved oxygen, pH, viable cell density probes), automation software, and optimized operating protocols for achieving high cell densities and titers. | Increases volumetric productivity, reduces bioreactor footprint and associated utility costs, improves process control and consistency, potentially shortens production cycle times. | Requires significant upfront investment in sensors and software. Requires skilled personnel for operation and data analysis. Training is crucial. |
| Strategic Raw Material Sourcing & Supply Chain | Long-term contracts or preferred supplier agreements for bulk procurement of critical raw materials (e.g., amino acids, salts, growth factors). May include pre-qualified vendors and inventory management support. | Lower unit costs due to bulk purchasing power, improved supply chain reliability, reduced administrative burden for procurement, potentially faster lead times. | Requires careful supplier qualification and auditing. Commitment to specific suppliers may limit flexibility. Forecasting accuracy is critical for inventory management. |
| Automation & Digitalization Solution | Bundled hardware (e.g., robotic liquid handlers, automated samplers) and software (e.g., LIMS, process analytical technology (PAT) platforms) designed to streamline upstream operations. | Reduces manual labor costs, minimizes human error, improves data integrity and traceability, enables real-time process monitoring and control, facilitates predictive maintenance. | Significant upfront investment. Requires IT infrastructure and skilled personnel. Integration with existing systems can be complex. Data security is paramount. |
Key Cost-Saving Strategies for Upstream Bioprocessing
- Media Optimization: Developing and utilizing cost-effective, high-performance cell culture media. This can involve custom formulations, reducing the reliance on expensive proprietary components, or exploring chemically defined media that offer greater consistency and potentially lower costs.
- Single-Use Technologies (SUTs): While initial investment can be a factor, SUTs can reduce capital expenditure, cleaning validation costs, and cross-contamination risks. Strategic implementation, focusing on critical steps, can offer significant long-term savings.
- Process Intensification: Designing processes that achieve higher cell densities and product titers in smaller bioreactor volumes. Techniques like fed-batch and perfusion cultures can dramatically improve productivity and reduce reactor footprint and associated utility costs.
- Automation and Digitalization: Implementing automation for routine tasks reduces labor costs and human error. Digital tools for process monitoring, control, and data analysis enable better decision-making, leading to improved efficiency and reduced waste.
- Scale-Up and Scale-Down Strategies: Developing robust scale-up models to minimize the number of intermediate-scale runs. Efficient scale-down models are critical for process development and troubleshooting, reducing the need for expensive large-scale experiments.
- Efficient Sterilization and Aseptic Techniques: Optimizing sterilization cycles and ensuring rigorous aseptic practices to minimize batch failures due to contamination, which represent a significant cost.
- Strategic Vendor Management and Procurement: Negotiating favorable terms with suppliers for consumables, raw materials, and equipment. Exploring bulk purchasing agreements and qualifying multiple suppliers to ensure competitive pricing and supply chain resilience.
- Waste Reduction and Recycling: Implementing programs to minimize waste generation, including media recycling (where applicable) and efficient disposal of biohazardous materials. Exploring opportunities for solvent recovery.
- Energy Efficiency: Optimizing utility usage (heating, cooling, air filtration) in bioprocessing facilities. This can involve energy-efficient equipment and smart facility design.
- Outsourcing and Contract Manufacturing: For companies with limited capital or expertise, leveraging contract development and manufacturing organizations (CDMOs) can be a cost-effective alternative to building and operating in-house facilities.
Verified Providers In Zambia
In Zambia, ensuring access to high-quality healthcare is paramount. 'Verified Providers' signifies a crucial standard, indicating that healthcare facilities and professionals have met stringent criteria for quality, safety, and ethical practice. Franance Health stands out as a leader in this domain, not only by adhering to these verification standards but by exceeding them. Their commitment to excellence translates into tangible benefits for patients, making them the best choice for healthcare needs in Zambia. This includes a focus on modern medical practices, patient-centric care, and a dedication to accessibility and affordability.
| Category | Franance Health Commitment | Patient Benefit |
|---|---|---|
| Quality Assurance | Exceeds all mandatory verification benchmarks. | Guaranteed access to safe, effective, and evidence-based medical treatments. |
| Patient Safety | Implements multi-layered safety protocols and continuous training. | Minimizes risks and ensures a secure healthcare environment. |
| Medical Expertise | Employs specialists in various fields with proven track records. | Receiving care from leading experts in their respective domains. |
| Infrastructure | Maintains modern facilities equipped with advanced medical technology. | Access to cutting-edge diagnostic and treatment capabilities. |
| Ethical Practice | Upholds strict ethical guidelines and patient rights. | Trustworthy and respectful treatment, with full transparency. |
Why Franance Health is the Top Choice for Verified Providers in Zambia:
- Rigorous Adherence to Verification Standards: Franance Health undergoes and consistently passes comprehensive audits for quality, safety, and ethical compliance.
- Patient-Centric Approach: Prioritizing patient well-being, comfort, and satisfaction through personalized care plans and attentive staff.
- Advanced Medical Technology and Practices: Investing in state-of-the-art equipment and staying abreast of the latest medical advancements to ensure optimal treatment outcomes.
- Highly Qualified and Experienced Professionals: Employing a team of skilled doctors, nurses, and support staff with extensive expertise and a passion for healthcare.
- Commitment to Accessibility and Affordability: Striving to make quality healthcare accessible to a broader population in Zambia.
- Transparent and Ethical Operations: Maintaining the highest standards of integrity and transparency in all aspects of service delivery.
Scope Of Work For Upstream Bioprocessing
This Scope of Work (SOW) outlines the requirements for upstream bioprocessing activities, focusing on the production of biological products. It details the technical deliverables and standard specifications essential for successful and reproducible manufacturing.
| Deliverable | Description | Standard Specifications/Acceptance Criteria |
|---|---|---|
| Fully Characterized Cell Line | Genetically stable cell line expressing the target product. | Demonstrated product expression levels, genetic stability over multiple passages, phenotypic characterization (growth rate, morphology), absence of adventitious agents (e.g., mycoplasma, viruses). |
| Optimized Growth Media Formulation | Defined or chemically undefined media composition that supports optimal cell growth and product titer. | Batch-to-batch consistency, defined component specifications, demonstrated performance in shake flasks/small-scale bioreactors, minimal lot variability. |
| Established Bioreactor Process Parameters | Defined setpoints for temperature, pH, dissolved oxygen (DO), agitation, aeration, feed rates, and induction strategies for optimal cell growth and product formation. | Process parameter ranges documented, validated for robustness, demonstrated to achieve target cell density and product titer. Control limits defined for IPCs. |
| Master Cell Bank (MCB) and Working Cell Bank (WCB) | Cryopreserved cell stocks that are well-characterized, sterile, and have demonstrated viability. | MCB and WCB vials, cell viability assay (≥ 90% post-thaw), sterility testing (e.g., USP <71>), mycoplasma testing (e.g., USP <63>), viral clearance studies (if applicable), identity testing (e.g., STR profiling). |
| Process Scale-up Report | Documentation detailing the successful transfer of the upstream process from laboratory to pilot or commercial scale. | Demonstration of equivalent or improved product titer and quality attributes at scale. Mass transfer, mixing, and heat transfer characteristics at scale confirmed. Process deviations and mitigation strategies documented. |
| In-Process Control (IPC) Specifications and Results | Defined analytical tests performed during the upstream process to monitor critical process parameters and product quality attributes. | Specific tests (e.g., cell count, viability, metabolite levels, product titer, impurity profiles), defined sampling frequency, acceptance criteria for each IPC, documented historical data demonstrating process control. |
| Harvest and Clarification Procedures | Defined methods for cell lysis (if applicable) and removal of cells and cell debris from the culture supernatant. | Defined method (e.g., centrifugation, filtration), demonstrated yield of clarified harvest, acceptable levels of residual cells and debris, process parameters defined and validated. |
| Batch Production Records (BPRs) | Comprehensive documentation of all activities performed during a specific manufacturing batch. | Adherence to approved master batch records, accurate recording of all process steps, deviations, and materials used. Signatures of operators and supervisors. |
| Process Validation Protocol and Report | Documentation outlining the plan and results for validating the upstream process to ensure consistent and reproducible product quality. | Defined critical process parameters (CPPs) and critical quality attributes (CQAs). Acceptance criteria for validation runs. Statistical analysis of data. Demonstration of process robustness. |
| Technology Transfer Documentation | All necessary documentation to enable the transfer of the upstream process to a different manufacturing site or facility. | Detailed process descriptions, BPRs, validation reports, analytical methods, raw material specifications, equipment list, training materials. |
Key Areas of Upstream Bioprocessing
- Cell Line Development and Characterization
- Media Development and Optimization
- Process Development and Optimization
- Cell Banking and Viability Testing
- Upstream Process Scale-up
- Master Cell Bank (MCB) and Working Cell Bank (WCB) Management
- Inoculum Train Development
- Bioreactor Operation and Control
- Monitoring and In-Process Controls (IPCs)
- Harvesting and Clarification
- Documentation and Regulatory Compliance
Service Level Agreement For Upstream Bioprocessing
This Service Level Agreement (SLA) outlines the response times and uptime guarantees for upstream bioprocessing services. It defines the commitments made by the service provider to the client regarding the availability and performance of the upstream bioprocessing systems and support.
| Service Component | Uptime Guarantee | Response Time (Critical Incident) | Response Time (Major Incident) | Response Time (Minor Incident) |
|---|---|---|---|---|
| Bioreactor System Availability | 99.5% | 1 hour | 2 hours | 4 hours |
| Cell Culture Media Preparation System | 99.0% | 1.5 hours | 3 hours | 6 hours |
| Upstream Process Monitoring & Control Software | 99.8% | 30 minutes | 1 hour | 3 hours |
| Data Acquisition & Logging System | 99.9% | 30 minutes | 1 hour | 3 hours |
| Technical Support (for operational issues) | N/A (covered by response times) | 1 hour (acknowledgement) | 2 hours (acknowledgement) | 4 hours (acknowledgement) |
Key Definitions
- Uptime: The percentage of time during a defined period that the upstream bioprocessing system is operational and available for use.
- Response Time: The maximum time allowed for the service provider to acknowledge and begin addressing a reported incident.
- Resolution Time: The maximum time allowed for the service provider to resolve a reported incident and restore normal service operation.
- Scheduled Maintenance: Planned downtime for system updates, upgrades, or preventive maintenance, communicated in advance.
- Unscheduled Downtime: Any period during which the upstream bioprocessing system is unavailable due to unforeseen issues or failures.
- Critical Incident: An event that causes a complete or significant disruption to upstream bioprocessing operations, impacting all or a majority of users/processes.
- Major Incident: An event that causes a partial disruption to upstream bioprocessing operations, impacting a significant portion of users/processes or critical functionalities.
- Minor Incident: An event that causes a minor disruption to upstream bioprocessing operations, impacting a limited number of users/processes or non-critical functionalities.
In-Depth Guidance
Frequently Asked Questions
Phase 02: Execution
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