Verified Service Provider in Namibia
Aseptic Fill-Finish Lines in Namibia
Engineering Excellence & Technical Support
Aseptic Fill-Finish Lines solutions for Bioprocessing & Manufacturing. High-standard technical execution following OEM protocols and local regulatory frameworks.
Automated Aseptic Filling Technology
Leveraging state-of-the-art automated aseptic filling machines ensures precise and sterile delivery of pharmaceutical products, minimizing human intervention and reducing contamination risks in our Namibian facilities. This technology guarantees product integrity and regulatory compliance for sensitive injectables and biologics.
Advanced Barrier Containment Systems
Our fill-finish lines are equipped with sophisticated Restricted Access Barrier Systems (RABS) and isolator technology. These advanced containment solutions create a highly controlled aseptic environment, safeguarding product sterility and operator safety within our Namibian operations, meeting stringent international GMP standards.
Rigorous Process Validation & Monitoring
Comprehensive validation protocols and continuous real-time environmental monitoring are integral to our aseptic fill-finish process in Namibia. This includes validated sterilization cycles, environmental monitoring of air particulates, microbial sampling, and integrity testing of sterile barriers to ensure consistent product quality and patient safety.
What Is Aseptic Fill-finish Lines In Namibia?
Aseptic fill-finish lines in Namibia refer to sophisticated manufacturing processes and integrated systems designed for the sterile filling and sealing of pharmaceutical products, particularly biologics, vaccines, and sterile injectables. This process is critical for maintaining product sterility from the point of filling into its primary container (vials, syringes, ampoules) to the final closure and packaging. The core principle is to prevent microbial contamination throughout the entire operation, ensuring the safety, efficacy, and shelf-life of sensitive drug products. These lines typically involve automated, high-speed machinery operating within highly controlled aseptic environments, often classified as ISO Class 5 (Grade A) cleanrooms. Key steps include sterilization of containers and closures, sterile product preparation and transfer, precise filling, stoppering, capping or sealing, and inspection, all conducted under strict aseptic conditions.
| Who Needs Aseptic Fill-Finish Services? | Typical Use Cases | |||||
|---|---|---|---|---|---|---|
| Pharmaceutical Manufacturers: Companies producing sterile injectable drugs, including novel biologics, biosimilars, and generic sterile products. | Biotechnology Companies: Developers and manufacturers of complex biological medicines such as monoclonal antibodies, vaccines, and cell/gene therapies. | Contract Manufacturing Organizations (CMOs) / Contract Development and Manufacturing Organizations (CDMOs): Organizations that provide specialized manufacturing services to other pharmaceutical and biotech companies. | Government and Public Health Agencies: For the production of essential vaccines and emergency-use medications. | Research and Development Institutions: For small-scale production of investigational new drugs (INDs) requiring sterile filling. | ||
| Vaccine Production: Filling and sealing of viral, bacterial, and mRNA-based vaccines. | Biologic Drug Manufacturing: Aseptic filling of therapeutic proteins, enzymes, and other complex biomolecules. | Sterile Injectable Pharmaceuticals: Production of antibiotics, anesthetics, chemotherapy drugs, and other injectable medications. | Ophthalmic Preparations: Sterile filling of eye drops and ointments. | Cell and Gene Therapy Products: Aseptic processing of advanced therapies requiring specialized handling. | Parenteral Nutrition Products: Sterile preparation and filling of intravenous feeding solutions. | Diagnostic Reagents: Sterile filling of diagnostic kits and solutions. |
Key Components and Processes of Aseptic Fill-Finish Lines
- Environmental Control: Rigorous control of air quality (HEPA filtration, particle counts, microbial monitoring), temperature, humidity, and pressure differentials.
- Sterilization of Components: Autoclaving or other validated sterilization methods for vials, stoppers, syringes, and other primary packaging materials.
- Product Preparation and Transfer: Aseptic handling and transfer of the bulk drug product from upstream processing to the filling machines.
- Filling: Precision volumetric filling using advanced dispensing systems (e.g., peristaltic pumps, piston pumps) to ensure accurate dosage and minimize product loss.
- Stoppering and Capping/Sealing: Automated placement of sterile stoppers and subsequent capping (e.g., aluminum seals) or sealing (e.g., crimping, welding) under aseptic conditions.
- Inspection: In-line or off-line inspection systems for particulate matter, fill level, and container integrity.
- Isolation Technology: Use of Restricted Access Barrier Systems (RABS) or isolators to create a physical barrier between operators and the product, further enhancing sterility assurance.
- Automated Handling and Robotics: Integration of robotic systems for precise manipulation of containers and components, reducing human intervention and potential contamination.
- Process Validation: Comprehensive validation studies to demonstrate the efficacy and reproducibility of the entire aseptic process.
- Quality Control and Assurance: Continuous monitoring and testing of critical process parameters and environmental conditions.
Who Needs Aseptic Fill-finish Lines In Namibia?
Aseptic fill-finish lines are specialized manufacturing facilities crucial for producing sterile pharmaceutical and biological products. These advanced systems ensure that injectable drugs, vaccines, and other sensitive medications are filled into their final packaging (vials, syringes, ampoules) in a completely sterile environment, preventing microbial contamination. In Namibia, as in any nation focused on public health and pharmaceutical self-sufficiency, these lines are indispensable for specific sectors within the healthcare and life sciences industries. Their adoption is driven by the need for high-quality, safe, and reliable sterile drug manufacturing.
| Customer Type | Key Departments Involved | Primary Needs & Applications |
|---|---|---|
| Local Pharmaceutical Manufacturers | Manufacturing, Quality Control (QC), Quality Assurance (QA), Research & Development (R&D), Supply Chain Management | Production of essential sterile medicines (e.g., antibiotics, analgesics), vaccines for national immunization programs, and potentially biosimil products. Ensuring compliance with international quality standards for export markets. |
| International Pharmaceutical Companies (with Namibian presence or partnerships) | Operations, Regulatory Affairs, Product Development, Supply Chain | Localizing production of critical sterile drugs to improve access and reduce import dependency. Serving the Namibian market and potentially regional export markets with their specialized sterile products (e.g., biologics, oncology drugs). |
| Biotechnology Companies | Process Development, Manufacturing, QC, QA, R&D | Production of sterile biopharmaceuticals, including monoclonal antibodies, recombinant proteins, and advanced therapies, requiring highly controlled aseptic conditions. Ensuring the stability and efficacy of complex biological products. |
| Government Health Agencies & National Pharmaceutical Companies | Procurement, Public Health Programs, Manufacturing (if applicable), Regulatory Compliance | Ensuring a secure and local supply of essential sterile medicines and vaccines for national health initiatives, emergency preparedness, and to combat public health crises. Reducing reliance on foreign supply chains. |
| Research Institutions | Clinical Trials, Drug Development, Manufacturing (small-scale) | Producing sterile drug products for clinical trials conducted within Namibia. Small-scale manufacturing of novel sterile therapeutics for research purposes. |
| Contract Manufacturing Organizations (CMOs) | Client Services, Manufacturing Operations, QA/QC, Business Development | Providing aseptic fill-finish services to other pharmaceutical and biotech companies that may not have their own sterile manufacturing capabilities, allowing them to outsource production of their sterile products. |
Target Customers and Departments for Aseptic Fill-Finish Lines in Namibia
- Pharmaceutical Manufacturers (Local and International with Namibian Operations)
- Biotechnology Companies
- Government Health Agencies & National Pharmaceutical Companies
- Research Institutions & Contract Manufacturing Organizations (CMOs)
Aseptic Fill-finish Lines Process In Namibia
This document outlines the typical workflow for establishing and operating aseptic fill-finish lines for pharmaceutical or sterile product manufacturing in Namibia, from the initial inquiry stage through to full execution and ongoing operations. Aseptic fill-finish is a critical process that ensures the sterility and integrity of parenteral products, requiring stringent controls and specialized equipment.
| Stage | Key Activities | Deliverables | Key Stakeholders | Typical Timeline (Indicative) |
|---|---|---|---|---|
| Phase 1: Inquiry and Needs Assessment | Initial contact with potential vendors/consultants. Defining product requirements, production volume, sterile requirements (e.g., ISO cleanroom classes), regulatory expectations (e.g., MCC, WHO GMP), and budget. | Request for Information (RFI), Initial Specification Document, Budgetary Estimates. | Client (Manufacturer), Regulatory Bodies (indirectly), Potential Vendors. | 1-3 Months |
| Phase 2: Feasibility Study and Planning | Detailed assessment of technical, economic, and regulatory feasibility. Site selection/evaluation (considering utilities, access, and environmental factors). Development of a comprehensive project plan, including timelines, risk assessment, and resource allocation. | Feasibility Report, Project Charter, High-Level Project Plan, Site Selection Report. | Client (Management, Engineering, Quality Assurance), Consultants, Potential Vendors. | 3-6 Months |
| Phase 3: Design and Engineering | Detailed design of the aseptic fill-finish line, including equipment selection (isolators, filling machines, stoppering machines, capping machines, inspection systems, sterilization equipment), cleanroom design and HVAC systems, utility provisions (WFI, clean steam, compressed air), automation and control systems, and material/personnel flow. | Detailed Engineering Drawings, Equipment Specifications, P&ID (Piping and Instrumentation Diagrams), Cleanroom Layouts, HVAC Design Documents, URS (User Requirement Specification). | Client (Engineering, QA, Production), Equipment Vendors, Engineering Consultants, Cleanroom Specialists. | 6-12 Months |
| Phase 4: Procurement and Manufacturing | Tendering and selection of equipment vendors. Manufacturing of specialized equipment according to approved designs and specifications. Pre-shipment factory acceptance tests (FAT). | Purchase Orders, Manufacturing Progress Reports, FAT Certificates. | Client (Procurement, Engineering, QA), Equipment Vendors. | 12-24 Months |
| Phase 5: Installation and Commissioning | Site preparation (construction of cleanrooms, utility installation). Installation of all equipment. Pre-operational checks and initial system testing (commissioning). Integration of all components of the fill-finish line. | Installed Equipment, Commissioning Protocols and Reports, Utility Qualification (initial). | Client (Engineering, Maintenance, QA), Installation Teams, Equipment Vendors, Commissioning Engineers. | 6-12 Months |
| Phase 6: Qualification and Validation | IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification) of the aseptic fill-finish line and associated cleanroom environments. Process validation for the specific drug products. Validation of sterilization processes. | IQ/OQ/PQ Protocols and Reports, Process Validation Reports, Cleaning Validation Reports, Sterilization Validation Reports, Media Fill Reports. | Client (QA, Validation Team, Production), External Validation Consultants, Regulatory Bodies (review). | 9-18 Months |
| Phase 7: Training and Handover | Comprehensive training of production, maintenance, and quality control personnel on operating, maintaining, and validating the aseptic fill-finish line. Formal handover of the completed and qualified facility. | Training Materials, Training Records, Handover Documentation, Standard Operating Procedures (SOPs). | Client (HR, Production, Maintenance, QA), Vendors (for equipment training). | 2-4 Months |
| Phase 8: Routine Operation and Maintenance | Initiation of commercial or pilot production runs. Ongoing monitoring of environmental conditions, equipment performance, and product quality. Scheduled preventive maintenance and calibration of equipment. Adherence to all SOPs and GMP guidelines. | Batch Production Records, Environmental Monitoring Data, Maintenance Logs, Calibration Records, Deviations and CAPA Reports. | Client (Production, QA, QC, Maintenance). | Ongoing |
| Phase 9: Ongoing Improvement and Compliance | Regular performance reviews, identification of areas for improvement, implementation of new technologies or process enhancements. Regular internal audits and preparation for regulatory inspections. Life cycle management of equipment and processes. | Audit Reports, Continuous Improvement Plans, Change Control Records, Regulatory Inspection Readiness Documents. | Client (Management, QA, Operations). | Ongoing |
Aseptic Fill-Finish Lines Process in Namibia: Workflow Stages
- Phase 1: Inquiry and Needs Assessment
- Phase 2: Feasibility Study and Planning
- Phase 3: Design and Engineering
- Phase 4: Procurement and Manufacturing
- Phase 5: Installation and Commissioning
- Phase 6: Qualification and Validation
- Phase 7: Training and Handover
- Phase 8: Routine Operation and Maintenance
- Phase 9: Ongoing Improvement and Compliance
Aseptic Fill-finish Lines Cost In Namibia
The cost of aseptic fill-finish lines in Namibia is a complex calculation influenced by numerous factors. These lines are sophisticated pieces of pharmaceutical manufacturing equipment designed for sterile filling of liquid or semi-solid products into final packaging, such as vials, syringes, or cartridges. Their high precision, automation, and stringent sterility requirements contribute to their significant price point. Namibian businesses seeking to invest in such technology must consider both the initial capital expenditure and ongoing operational costs, all within the local economic context and currency (Namibian Dollar - NAD).
| Aseptic Fill-Finish Line Type (Indicative) | Estimated Price Range (NAD) | Key Considerations |
|---|---|---|
| Basic Semi-Automated Line (Low to Medium Capacity) | NAD 2,000,000 - NAD 7,000,000 | Suitable for smaller-scale production, simpler products, and fewer packaging options. May require more manual intervention. Likely to be more prevalent in refurbished markets. |
| Medium-Sized Automated Line (Medium Capacity) | NAD 7,000,000 - NAD 25,000,000 | Offers a balance of automation and capacity for typical pharmaceutical production. Can handle a range of liquid products and common packaging formats. Includes integrated sterilization and basic inspection. |
| High-Capacity Fully Automated Line (High Throughput) | NAD 25,000,000 - NAD 80,000,000+ | Designed for large-scale, high-speed production. Features advanced robotics, comprehensive inline inspection, serialization capabilities, and advanced sterilization. Suitable for high-demand products like vaccines. |
| Specialized Lines (e.g., Pre-filled Syringes, Biologics) | NAD 40,000,000 - NAD 150,000,000+ | Tailored for highly specific and sensitive products. May include advanced aseptic handling, unique filling technologies, and stringent environmental controls. Costs are highly variable based on complexity. |
| Refurbished Lines | NAD 1,000,000 - NAD 15,000,000 | Prices vary significantly based on age, condition, original specifications, and extent of refurbishment. A viable option for cost-conscious businesses, but requires thorough due diligence. |
Key Pricing Factors for Aseptic Fill-Finish Lines in Namibia:
- Line Complexity and Automation Level: More automated and complex lines with integrated inspection, capping, and labeling systems will command higher prices.
- Production Capacity and Speed: Higher throughput requirements necessitate larger, faster, and more robust machinery, increasing cost.
- Product Type and Packaging: Filling different types of products (e.g., biologics, vaccines, parenteral drugs) and various packaging formats (vials, syringes, ampoules, pre-filled syringes) require specialized configurations and accessories.
- Sterilization Technology: The type of sterilization employed (e.g., hydrogen peroxide vapor, gamma irradiation compatibility) impacts the system's design and cost.
- Integration with Upstream and Downstream Processes: The need for seamless integration with upstream sterile product preparation and downstream packaging, labeling, and serialization equipment affects the overall system cost.
- Regulatory Compliance and Validation: Meeting stringent pharmaceutical standards (e.g., GMP, FDA, EMA) requires advanced features, documentation, and rigorous validation processes, which add to the price.
- Supplier and Brand Reputation: Established, reputable manufacturers often have higher prices due to their proven track record, quality, and after-sales support.
- New vs. Refurbished Equipment: New, state-of-the-art lines are considerably more expensive than well-maintained refurbished units, though the latter may have shorter lifespans or require more frequent maintenance.
- Customization and Specific Features: Bespoke modifications or specialized features to meet unique production needs will increase the cost significantly.
- Installation, Commissioning, and Training: The cost of expert installation, on-site commissioning, and comprehensive operator/maintenance training provided by the supplier is a crucial component of the overall investment.
- After-Sales Support and Maintenance Contracts: Ongoing service agreements, spare parts availability, and remote diagnostics contribute to the long-term cost of ownership.
- Import Duties, Taxes, and Logistics: For equipment imported into Namibia, customs duties, VAT, freight, insurance, and local transportation will add a substantial percentage to the landed cost.
- Exchange Rates: Fluctuations in the NAD against major currencies (USD, EUR) can significantly impact the final price of imported equipment.
- Local Supplier Markup: If purchasing through a Namibian distributor or agent, their markup will be factored into the price.
Affordable Aseptic Fill-finish Lines Options
Acquiring an aseptic fill-finish line represents a significant capital investment for pharmaceutical and biotech companies. While high-end, fully automated lines offer unparalleled speed and precision, their cost can be prohibitive, especially for emerging companies, contract manufacturing organizations (CMOs) entering new markets, or those with lower production volume needs. Fortunately, several "affordable" aseptic fill-finish line options exist. These often involve strategic compromises in automation, modular designs, and careful consideration of total cost of ownership. This exploration focuses on value bundles and cost-saving strategies to make aseptic fill-finish capabilities more accessible.
| Value Bundle Component | Description | Cost-Saving Implication |
|---|---|---|
| Pre-Configured 'Starter' Lines | Standardized configurations designed for common applications (e.g., small-batch vial filling). These have predictable componentry and simplified engineering. | Reduced engineering design costs, faster lead times, and often a lower base price due to mass production of standard modules. |
| Semi-Automated Systems | Combine manual product loading/unloading or certain filling operations with automated capping, sealing, or inspection. Operators play a key role in the process. | Significantly lower capital expenditure compared to fully automated lines. Suitable for lower throughput requirements where labor is readily available. |
| Integration of Proven, Standard Components | Utilizing well-established and widely available components (pumps, sensors, valves) from reputable suppliers rather than highly specialized or custom-made parts. | Lower procurement costs, easier spare parts availability, and reduced risk of obsolescence. |
| Streamlined Sterilization and Cleanroom Integration | Focus on simpler barrier technologies (e.g., isolators with basic H2O2 decontamination cycles) and less complex cleanroom classifications where appropriate, aligned with product risk. | Reduced cost of containment solutions and associated HVAC and environmental monitoring systems. Avoids over-engineering for less sensitive products. |
| Software and Control Systems Optimized for Functionality | Using robust but less complex PLC-based control systems with essential HMI functionality, rather than highly advanced SCADA or MES integration as standard. | Lower software licensing and development costs. Can be upgraded to more advanced systems later if needed. |
| Training and Support Packages | Bundled training for operators and maintenance personnel, and well-defined service agreements that offer predictable maintenance costs. | Reduces the risk of operational errors due to insufficient training, minimizes downtime, and prevents unexpected repair expenses. |
| Refurbished or Certified Pre-Owned Equipment | Purchasing well-maintained and certified used aseptic fill-finish equipment from reputable vendors. | Significant upfront cost savings. Requires thorough due diligence on the equipment's condition and vendor's warranty/support. |
Defining Affordable Aseptic Fill-Finish
- {"title":"Beyond Initial Purchase Price: Total Cost of Ownership (TCO)","description":"Affordability isn't solely about the upfront equipment cost. TCO includes installation, validation, training, operational expenses (utilities, consumables), maintenance, and potential upgrades. Lower initial cost lines might have higher TCO if they are less efficient or require more manual intervention."}
- {"title":"Targeting Key Applications","description":"Affordable solutions are often designed for specific applications like vials, syringes, or cartridges, rather than highly versatile, multi-format lines. This specialization reduces complexity and, consequently, cost."}
- {"title":"Level of Automation","description":"The degree of automation is a primary cost driver. Semi-automated or manually assisted lines are significantly less expensive than fully robotic systems. This necessitates more operator involvement but can be a viable option for lower throughputs."}
- {"title":"Modular and Scalable Designs","description":"Many cost-effective lines are built on modular principles. This allows for a smaller initial footprint and capability, with the ability to add modules or upgrade automation as production needs grow, spreading the investment over time."}
Verified Providers In Namibia
In Namibia's evolving healthcare landscape, identifying genuinely 'verified providers' is crucial for ensuring quality and trust. Franance Health stands out by adhering to stringent credentialing processes and demonstrating a commitment to excellence, making them a top choice for your healthcare needs. Their verified status signifies a rigorous vetting of their medical professionals and facilities, ensuring they meet and exceed established standards.
| Feature | Franance Health (Verified Providers) | Standard Providers (Unverified) |
|---|---|---|
| Credential Verification | Comprehensive background checks, license verification, and peer review. | May vary, often limited to basic registration. |
| Quality Assurance | Ongoing monitoring and adherence to strict quality protocols. | Less formalized, relies on individual practice. |
| Patient Safety | Prioritized through stringent vetting and adherence to best practices. | Can be inconsistent. |
| Trust and Reliability | High due to transparent and rigorous verification processes. | Requires individual research and potentially higher risk. |
| Professional Development | Encouraged and often mandated for continued excellence. | Optional or based on individual initiative. |
Why Franance Health is the Best Choice for Verified Healthcare in Namibia:
- Rigorous Credentialing: Franance Health's providers undergo a comprehensive verification process, checking qualifications, licenses, and disciplinary history.
- Commitment to Quality: Their focus extends beyond basic certification to a continuous improvement in patient care and service delivery.
- Patient-Centric Approach: Verified providers at Franance Health prioritize patient well-being and aim for optimal health outcomes.
- Transparency and Trust: The 'verified' status offers peace of mind, assuring patients they are receiving care from reputable and competent professionals.
- Access to Expertise: Franance Health connects you with a network of specialists and general practitioners who have met the highest standards.
Scope Of Work For Aseptic Fill-finish Lines
This document outlines the Scope of Work (SOW) for the design, procurement, installation, commissioning, and validation of Aseptic Fill-Finish Lines. It details the technical deliverables required and standard specifications to ensure compliance with regulatory requirements and operational efficiency.
| Phase | Key Activities | Technical Deliverables | Standard Specifications |
|---|---|---|---|
| Project Planning and Definition | Requirements gathering, feasibility study, conceptual design, vendor selection criteria development. | Project Charter, User Requirement Specification (URS), Conceptual Design Report, Risk Assessment Plan. | FDA 21 CFR Part 210/211, EU GMP Annex 1, ISPE Baseline® Guide Series, Project Management Institute (PMI) standards. |
| Engineering Design and Procurement | Detailed engineering design, P&ID development, equipment specification, vendor selection and purchase order issuance. | Detailed P&IDs, Equipment General Arrangement Drawings, Electrical Schematics, Instrumentation Lists, Bill of Materials (BOM), Purchase Orders. | ASME BPE, PED, ATEX, UL/CSA standards, relevant industry best practices for aseptic processing. |
| Manufacturing and Assembly | Fabrication of major equipment components, skid assembly, internal testing by vendors. | FAT (Factory Acceptance Test) protocols and reports, material certificates, welding procedures, vendor assembly documentation. | ISO 9001, ASME fabrication codes, vendor-specific quality management systems. |
| Installation and Integration | Site preparation, equipment erection, utility connections (WFI, clean steam, compressed air, power), inter-equipment piping, control system integration. | Installation Qualification (IQ) protocols and reports, Site Acceptance Test (SAT) protocols and reports, as-built drawings, calibration certificates. | cGMP requirements for facility design and construction, cleanroom classification standards (ISO 14644), relevant electrical and mechanical codes. |
| Commissioning and Qualification | Performance testing, operational verification, cleaning validation, process validation (PV) master plan development. | Performance Qualification (PQ) protocols and reports, Cleaning Validation protocols and reports, Process Validation (PV) protocols and reports, O&M Manuals. | ICH Q7, ICH Q8, ICH Q9, ICH Q10 guidelines, regulatory agency guidance documents (e.g., FDA Process Validation Guidance). |
| Validation and Handover | Final validation report compilation, regulatory submission support, training of personnel, project closeout. | Validation Summary Report, final as-built documentation package, training records, project closure report. | Regulatory agency specific requirements, internal SOPs, quality management system requirements. |
Key Phases of the Project
- Project Planning and Definition
- Engineering Design and Procurement
- Manufacturing and Assembly
- Installation and Integration
- Commissioning and Qualification
- Validation and Handover
Service Level Agreement For Aseptic Fill-finish Lines
This Service Level Agreement (SLA) outlines the guaranteed response times and uptime for the Aseptic Fill-Finish Lines. It is designed to ensure minimal disruption to production and maintain the highest standards of quality and compliance.
| Service | Definition | Guaranteed Uptime | Response Time (Critical Failure) | Response Time (Major Issue) | Response Time (Minor Issue) | |||
|---|---|---|---|---|---|---|---|---|
| Line Operation | Successful and continuous aseptic filling, stoppering, and capping of product within the specified process parameters. | 98.5% (excluding scheduled maintenance and planned downtime) | 1 hour (acknowledgement) | 4 hours (initiation of corrective action) | 8 business hours (initiation of corrective action) | 2 hours (initiation of corrective action) | 8 business hours (initiation of corrective action) | 24 business hours (initiation of corrective action) |
| Environmental Controls (Isolator/RABS) | Maintenance of critical environmental parameters (e.g., particle counts, pressure differentials, temperature, humidity) within the sterile zone. | 99.0% (excluding scheduled maintenance and planned downtime) | 1 hour (acknowledgement) | 4 hours (initiation of corrective action) | 8 business hours (initiation of corrective action) | 2 hours (initiation of corrective action) | 8 business hours (initiation of corrective action) | 24 business hours (initiation of corrective action) |
| CIP/SIP Systems | Successful execution of Cleaning-In-Place (CIP) and Sterilization-In-Place (SIP) cycles for the fill-finish lines and associated components. | 97.0% (excluding scheduled maintenance and planned downtime) | 2 hours (acknowledgement) | 6 hours (initiation of corrective action) | 16 business hours (initiation of corrective action) | 4 hours (initiation of corrective action) | 16 business hours (initiation of corrective action) | 48 business hours (initiation of corrective action) |
Scope of Agreement
- Aseptic Fill-Finish Line 1
- Aseptic Fill-Finish Line 2
- Associated Ancillary Equipment (e.g., isolators, CIP/SIP skids, upstream/downstream conveyors directly feeding/receiving from the fill-finish lines)
In-Depth Guidance
Frequently Asked Questions
Phase 02: Execution
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