Training Facility
Sequence has executed a vision to build a fully functional, mock pharmaceutical manufacturing training facility to educate and prepare our team of consultants in a way the industry hasn’t seen before.
Key attributes
- Fully Functional
- Real-life Setting
- Hands-on Experience
The Sequence solution
Accelerating Knowledge to Increase Speed to Market
Sequence has executed a vision to build a fully functional, mock pharmaceutical manufacturing training facility to educate and prepare our team of consultants in a way the industry hasn’t seen before.
We provide exposure to process equipment and software applications in a real-life setting. We intentionally include a wide range of systems and software our consultants will encounter on job sites to increase their knowledge across multiple platforms.
This level of exposure and hands-on experience, together with education on the latest industry trends, provides the advantage of accelerated knowledge equivalent to years of experience in many cases. This allows our consultants to be immediately impactful on the job site no matter how many years they’ve been in the industry.
Innovative training
How we're different
Our cross-functional approach to training our consultants is unique and provides greater value for our clients and employees because we teach risk mitigation through the understanding of implications and impact to all areas within a facility. This is further enhanced by our hiring practice based on our ideal candidate profile to ensure success from the beginning.
Our revolutionary training facility allows us to provide continuing education for our more experienced team members and accelerated learning for newer team members.
Hands-on Learning
Direct exposure and hands-on learning with equipment and systems in a real-life application setting.
Product & Process Knowledge
Targeted training focused on translating product and process knowledge into quality driven design requirements and efficient risk-based testing strategies.
Exposure to Multiple Platforms
Exposure to a wide range of Digital Solutions including BMS, PCS and MES.
Accelerated Training
Accelerated training that provides the equivalent of years of growth and development in a short period of time.
Cross-Functional Approach
Incorporates all elements to conceptually train resources on all aspects of plant operations: facilities, utilities, lab, IT, manufacturing process (upstream & downstream), filling, automation, and ancillary equipment with a Pharma 4.0 infrastructure.
Why it matters
A Cross-Functional Approach to CQV and Digital Solutions
Focus on product and process knowledge
Our training program is focused on making sure our employees develop an understanding of how to apply both regulation and guidance to the validation lifecycle, specifically focusing on design, commissioning, and qualification of new facilities.
Exposure to Latest industry guidance
We provide exposure to the latest Industry guidance, so they understand what it takes to create strategies to achieve compliance. This includes ISPE, USP, ICH, FDA and ISA.
Accelerated Learning
The rapid acceleration of knowledge is what sets our team of consultants apart by creating a level of understanding that will ultimately increase speed to market for the life impacting drugs our clients are manufacturing.
Digital Solutions Understanding
Exposure to a wide range of Digital Solutions including BMS, PCS and MES.
Cross Functional Understanding
Incorporates all elements to conceptually train resources on all aspects of plant operations: facilities, utilities, lab, IT, manufacturing process (upstream & downstream), filling, automation, and ancillary equipment with a Pharma 4.0 infrastructure.
Hands-on Learning Makes a Difference
To accelerate our team’s knowledge, our hands-on training facility is set up to represent a mock pharmaceutical manufacturing facility with five core areas of focus for our training: Facilities, Equipment, Utilities, Lab and Computerized Systems.
Manufacturing Area
Manufacturing Area
Our focus
We’re establishing an understanding of the engineering principles driving the functionality of common systems involved in converting raw materials into finished pharmaceutical products that meet established quality standards.
What We’re Learning
- Upstream Processing
- Cell Culture
- Growing cells in a single use application to achieve viable cell density requirements
- DO control, pH control, Temperature control
- Induction/Infection/Transfection of cells for product generation
- Harvest filtration principles and control strategies
- Single use instrumentation and associated control strategies
- Filter integrity testing principles and execution
- Viral Inactivation
- Single use mixer functionality to support reduction of viral load
Downstream Processing
- Chromatography
- Complex flow control to achieve residence time with column resin
- Sequence of operations to achieve desired purification
- Utilizing inline UV instrumentation to control product collection
- Cleaning principles of process piping and resin
- Ultrafiltration/Diafiltration
- Complex pressure control to achieve concentration and diafiltration
Filling
- Principles of 100% check weight and application for serialization
- Achieving sterility in an aseptic environment
Distributed Control System
- Supervisory control and data acquisition appropriate for local PLCs
- Networking principles and communication of non-native devices
- Centralized and de-centralized I/O networks
Utilities Area
Utilities Area
Our Focus
To establish an understanding of the engineering principles driving the functionality of common systems involved in utility generation and distribution and functionality of support equipment used for cleaning, sterilizing and solution preparation.
What We’re Learning
- Clean utility performance (water, steam, gases)
- Purity and Quality
- Loop sizing for sufficient distribution
- Not Direct Impact Utilities
- Hydronic fluid generation and Distribution
- Lead/Lag functionality
- Non-Hygienic piping requirements
- Cleaning
- CIP/COP Cycle Development
- Riboflavin/Unsoiled/Soiled
- Load Studies
- Decontamination
- Sterilization and lethality principles
- Steam quality testing
- Load studies (temperature/biological Indicator mapping)
- Solution preparation and distribution
- Process Control
- Variety of local process control systems
- Loop checks and wiring walkdowns
- Sequence of operations, alarming, interlocks, etc.
- Part 11 compliance
- Hygienic Piping
- Sample spool piece with turnover package
- Weld demonstration coupon panel
- Electrical Distribution
- Walkdowns including junction boxes, disconnects, receptacles
Analytical Lab
Analytical Lab
Our Focus
To establish an understanding of the engineering principles driving the functionality of common analytical instrumentation and associated methods. These principles are applied to evaluate system capability to confirm quality standards including purity, potency, stability and safety.
What We’re Learning
Analytical Instrument Qualification
- Vendor Functional Design
- Examples of utilizing vendor design documentation for simple systems and learning when supplemental design documents are required for specific use-cases
- Evaluating vendor-built methods to determine when custom method development is required
- Employing GAMP Category 4 level testing for configurable vendor-driven methods
- Employing GAMP Category 5 level testing when custom methods are required
- Filter Integrity Tester
- Example of precision pressure meters utilized for bubble point, diffusion, and other FIT methods
- Collaborating with manufacturing area equipment to build configuration specifications for the required filter methods
- Benchtop Centrifuge
- Practicing Performance Qualifications
- UV/Vis Spectrophotometer and pH Analyzer
- Establishing the differences between calibration and standardization
- Establishing the differences between instrument capability, equipment capability, and process requirements
- Kaye Validator and Oil Bath
- Equipment used in supporting qualification must also be qualified
- Requires coordination with other areas that utilize the Kaye to execute required testing
Microbiology Lab
Microbiology Lab
Our focus
To establish an understanding of the engineering principles driving the functionality of common microbial identification and detection instrumentation and associated methods. These principles are applied to evaluate system capability to monitor the presence of microorganisms throughout the drug development and production process.
What We’re Learning
Microbial identification
- Identification and classification of microorganisms that may be present in samples collected from various stages of drug development, production, and testing.
Microbial detection
- Determining the presence or absence of microorganisms from samples (i.e., Sterility)
Antimicrobial susceptibility
- Test the efficacy of antimicrobial agents used against a variety of microorganisms to determine treatment options.
- Typically seen in clinical spaces, it can prove useful when characterizing organisms commonly identified within the process.
Exposure to regulatory requirements and industry standards that guide microbial testing and handling, specifically USP chapters.
- <63> - Mycoplasma Tests
- <71> - Sterility Tests
- <1071> - Rapid Microbial Tests for Release of Sterile Short-Life Products: A Risk-Based Approach
- <1113> - Microbial Characterization, Identification, and Strain Typing
- <1223> - Validation of Alternative Microbiological Methods
Networking
Networking
Our Focus
To gain an understanding of data aggregation and system to system interfacing commonly seen in Pharma 4.0 applications. Networking principles, including on-premise and cloud-based infrastructures, are important in ensuring data integrity requirements are maintained during collection and storage over defined retention periods.
What We're Learning
- VLAN configuration and port assignments
- Significance of IP addresses, port forwarding, etc.
- Virtualization (allocation of physical resources, etc.)
- Secure access to SaaS applications
- Cyber security concepts (firewalls, demilitarized zones, etc.)
- Network panel and associated hardware walkdowns
- Redundancy and failover configuration
Digital Solutions
Digital Solutions
Our Focus
Provide a fully integrated digital infrastructure that facilities a deeper level understanding of a wide variety of digital platforms used to support manufacturing processes.
What We're Learning
- Process control system integration (Local control, DCS, etc.)
- Manufacturing Execution Systems
- Equipment tracking (OEE, hygienic status, etc.)
- Production Control (job aids, SOPs, batch records, etc.)
- Supply chain and inventory management practices (ERP)
- Calibration and Maintenance (CMMS)
- Analytical results (LIMS)
- Data Analytics
- Electronic Execution System (EES)
Lecture Room
Lecture Room
Our Focus
Understanding how to apply both regulation and guidance to the validation lifecycle, specifically focusing on design, commissioning, and qualification of new facilities.
What We're Learning
- How to translate Regulations, Company Standards, Product and Process Knowledge into a compliant manufacturing facility that is fit for intended use
- Exposure to Industry guidance that help create strategies to achieve compliance
- ISPE/USP/ICH/FDA/ISA
- Process qualification adhering to FDA Guidance
- Validation Plans
- Requirement Specifications (User and Functional)
- Risk Assessments
- Detailed Designs
- Design Reviews and Design Qualifications
- Turnover Packages
- Testing
- Vendor Leveraging
- FAT/SAT/IOQ
- Commissioning and Qualification/Verification
- Vendor Leveraging
- Trace Matrices
- Summary Reports
Warehouse
Warehouse
Our Focus
Understanding warehouse functionality as it relates to storage, organization, distribution of raw materials, finished product and other various supplies for operations.
What We're Learning
- Future location for packaging equipment used for training
- Simulated environment for digital supply chain management
- Inventory management (barcode scanners, etc.)
- Track and Traceability (raw material, final product shipments, etc.)
- Storage of our raw material for training purposes
- Environmental monitoring (temperature/humidity mapping)
Other Uses
- Maintenance of existing equipment (access to wall panel utilities)
- FAT testing and temporary equipment staging for clients
Personnel and Material Flow
Personnel And Material Flow
Our Focus
Personnel and material flow and its impact on environmental conditions for classified areas.
What We're Learning
Gowning Ante-Room
- Proper aseptic gowning techniques
- Use of makeup, jewelry, cell phones, etc. in cleanroom environments
- Captive PPE
- Decontaminating raw material and incoming supplies
Supply/Return Corridor
- Classified cleanroom concepts
- Environmental monitoring
- Temperature/Humidity
- Viable and non-viable particulates
- Differential pressure (Sinks/Bubbles)
- Air flow exchanges and adequate air flow rates
- Controlled access and designated personnel/material flow to certain areas within a facility.
- Door Interlocks
Our goal is to change the standard approach to Commissioning, Qualification and Validation (CQV) and Digital Solutions when setting up a facility to be fit for intended use.
Through our 20+ years of experience, our success is measured through our ability to help our clients in a more efficient and effective manner and accelerate time to market for the drugs that will ultimately impact patient lives.