- Date:
-
- Seminar
GMP-gerechte Reinräume (PT 19) - Planen - Bauen - Betreiben
- Event location:
- Mannheim
- Organizer:
- CONCEPT HEIDELBERG GmbH
GMP Regulations Block
Knowing the regulatory requirements is the fundamental prerequisite for all subsequent steps such as: design, construction, and operation of cleanrooms and HVAC systems. Annex 1 of the EU GMP Guide and the Aseptic Guide of the FDA are integral parts of daily handling of the topic of cleanroom technology. These are supplemented by numerous standards, such as ISO 14644 and VDI 2083 series, as well as some other documents, especially when deriving requirements for non-sterile manufacturing.
Knowing the regulatory requirements is the fundamental prerequisite for all subsequent steps such as: design, construction, and operation of cleanrooms and HVAC systems. Annex 1 of the EU GMP Guide and the Aseptic Guide of the FDA are integral parts of daily handling of the topic of cleanroom technology. These are supplemented by numerous standards, such as ISO 14644 and VDI 2083 series, as well as some other documents, especially when deriving requirements for non-sterile manufacturing.
Regulatory Requirements for Cleanrooms
- EU-GMP Guide Part 1, Annex 1 and 15, news?!
- Impacts of the new chapters 3 and 5 of the EU GMP Guide
- Requirements of the European Pharmacopoeia
- Isolator and RABS from a regulatory perspective
- Experience from inspection practice: layout and on-site walkthrough
Introduction to Air Technology
- Requirements for HVAC systems
- Specific standards & guidelines
- Cleanroom technical protection concepts
- Concept variants
- Basic sizes and their relationships
- Cleanroom class
- Air change rate
- Recovery time
- Flow velocity
- Flow direction
- Design criteria for HVAC systems
- Basics of filter technology
Cleanroom Planning Block
Essential for the success of developing a layout is the consideration of relationships between process steps and the various flows. Developing process, block, or Sankey diagrams is particularly helpful.
Essential for the success of developing a layout is the consideration of relationships between process steps and the various flows. Developing process, block, or Sankey diagrams is particularly helpful.
Layout – Basics
Consideration of framework conditions for creating layouts
- Technology
- Overview of product groups
- Applicable cleanroom classes
- Single- or multi-story concept
- "Lean Manufacturing"
- Building
- Minimum / maximum number of building floors
- Optimal placement of technical areas
- Walkable ceilings yes / no
- Optimal floor heights, support column spacing / grid sizes
- Corridor concepts, corridor
- Development Plan
- Plot: restrictions, legal requirements
- Relationships to existing infrastructure
Workshop 1: Development of a Layout Concept
In an example from the liquid forms (sterile), you will learn in the first workshop how to determine space and surface requirements as well as their functional coherence and cleanroom classes based on given requirements and technologies.
In an example from the liquid forms (sterile), you will learn in the first workshop how to determine space and surface requirements as well as their functional coherence and cleanroom classes based on given requirements and technologies.
The following are specified and explained in this example:
- Requirements and necessary functions
- Process & material flows (schematic)
- Required process equipment
You will develop from this in a group work:
- The list of required rooms and their functional coherence
- A rough surface estimate of the rooms
- The applicable cleanroom classes
Layout – Detailed Planning
Development of a sample layout for "Solid Forms" (an example for sterile medicinal forms will be part of the workshop)
Development of a sample layout for "Solid Forms" (an example for sterile medicinal forms will be part of the workshop)
- Requirements and processes
- Products and required functions
- Process & material flows (schematic)
- Required process equipment
- General layout concept
- Building layout
- Sensible arrangement of functional modules
- Expansion possibilities
- Deepening into a detailed layout
- Listing of required rooms according to function
- Surface estimation of the rooms
- Applicable cleanroom classes
- Architecture and equipment layout
- Hygiene zones and flows
- Pressure zone concept
Workshop 2: Layout Detail Development
In the second workshop, you will continue the planning from the first workshop and create a functional layout.
You will develop in a group work:
In the second workshop, you will continue the planning from the first workshop and create a functional layout.
You will develop in a group work:
- A layout with functionally sensible arrangement of rooms
- With hygiene zones
- With personnel flow and material flow
- With pressure zone concept
Concrete Examples of Zone and Shuttle Concepts
- Cleanroom concepts in international comparison
- Practical examples of cleanroom concepts for
- Aseptic manufacturing
- Aseptic manufacturing of highly active substances
- Sterile preparations in pharmacies
- Manufacture of solid dosage forms
- Manufacture of solid, highly active dosage forms
- Shuttle concepts for different manufacturing types
- Classic A/B concept and use of barrier systems
- Integration of process equipment into the cleanroom
Cleanroom Construction Block
Guidelines and standards relevant to pharmaceutical cleanrooms allow the derivation of a number of fundamental parameters, which influence the design of the rooms as well as their execution. The prerequisite for implementing these requirements is knowledge of the fundamentals of cleanroom technology.
Guidelines and standards relevant to pharmaceutical cleanrooms allow the derivation of a number of fundamental parameters, which influence the design of the rooms as well as their execution. The prerequisite for implementing these requirements is knowledge of the fundamentals of cleanroom technology.
Cleanroom Wall and Ceiling Systems
- Definition of requirements from building law, construction technology / building design, and operational and GMP reasons
- Overview of various cleanroom wall and ceiling systems
- Systems in monoblock construction
- Systems in shell construction
- Glass systems
- Gypsum board partition walls
- Components of wall systems: connections, doors, windows, edge protection
- GMP-specific requirements for ceiling and wall systems
- Planning of the appropriate ceiling and wall system
- Specification and tendering
- Advantages and disadvantages of different systems
- Quality assurance, acceptance documentation, qualification
The Cleanroom Floor System
- Definition of requirements from operational and GMP reasons
- Substrate requirements
- Refurbishment of old floors: renovation or demolition?
- Mechanical, thermal, chemical, drainable properties
- Slip resistance vs. GMP
- Surface coverings for different uses
- Overview of GMP-compliant cleanroom floor systems up to class E
- Pharma terrazzo
- Alternative coverings made of hard material screed, rubber, PVC and their applications
- Wall connections, coves, silicone joints, and other important details
- Quality assurance, acceptance documentation, qualification
Integration of an Isolator into the Production Area
- Interfaces to media and climate technology
- Placement considering the building and cleanroom concept
- Installation
- Operation
- Decontamination
Qualification Block
To perform pharmaceutical manufacturing steps in a cleanroom, complete qualification is required. This applies to both the premises and the air technical systems and filters.
The formal requirements for qualification do not differ between cleanrooms for sterile or non-sterile medicinal forms, but the content to be checked and fulfilled does.
To perform pharmaceutical manufacturing steps in a cleanroom, complete qualification is required. This applies to both the premises and the air technical systems and filters.
The formal requirements for qualification do not differ between cleanrooms for sterile or non-sterile medicinal forms, but the content to be checked and fulfilled does.
Qualification of a Cleanroom
- Engineering – Specification sheet, requirements specification, SAT, FAT
- Qualification planning, requirement matrix, risk analysis
- Design qualification and supplier audit
- Procedure for IQ
- Handling of installations and media
- OQ and PQ
- Microbiology in PQ – Data evaluation
- Acceptance and qualification measurements
- Typical deficiencies in rooms
Cleanroom Operation Block
Depending on requirements, continuous or periodic particle monitoring is performed. Microbiological monitoring is documented in monitoring plans. Now, cleaning, staff training, and maintenance play important roles. Deviations and changes must be documented in GMP-compliant manner.
GMP-compliant Operation of a Cleanroom
Depending on requirements, continuous or periodic particle monitoring is performed. Microbiological monitoring is documented in monitoring plans. Now, cleaning, staff training, and maintenance play important roles. Deviations and changes must be documented in GMP-compliant manner.
GMP-compliant Operation of a Cleanroom
- Mapping to identify critical points
- Cleaning and validation of cleaning
- Transition to microbiological routine monitoring in aseptic and non-sterile areas
- Particle monitoring during ongoing sterile/non-sterile operation
- Maintenance of cleanrooms
- Deviations and changes in the cleanroom
- Review and requalification
CONCEPT HEIDELBERG GmbH
Rischerstraße 8
69123 Heidelberg
Germany
Phone: +49 6221 844415
Fax: +49 6221 844464
email: info@concept-heidelberg.de
Internet: http://www.gmp-navigator.com/
