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Optimizing Cleaning with CIP Systems

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Create a professional corporate-style presentation based on the thesis 'Optimierung der Reinigungen durch Einführung von CIP-Systemen' by Mady Berthe (Carbogen Amcis AG, 2025). Use the following structure and timing: 1. Titelfolie (0:30 min) – Project title, name, date, department 'Produktion Neuland', include image from cover page. 2. Einleitung & Kontext (2 min) – Overview of Carbogen Amcis AG, API manufacturing, GMP requirements, Neuland site details, mobile equipment use. 3. Problemstellung (2 min) – Time, resource, and solvent-intensive manual cleaning; difficult geometries; demounting issues; overcleaning; example of unresolved solid residues. 4. Zielsetzung (2 min) – Main goal: introduce a standardized, transferable CIP concept. Include SMART goals: standardization, waste reduction, safety, GMP compliance. 5. Projektorganisation (1:30 min) – Roles and departments: Production, QA/QS, MAI/Engineering, ESH. Include interface diagram (p.8). 6. Vorgehen (PDCA-Zyklus) (2:30 min) – PLAN (analysis, risk), DO (pilot setup), CHECK (tests, evaluation), ACT (SOPs, rollout). 7. Situationsanalyse & Reinigungsarten (2 min) – PR, ZR, SR cleaning types and weaknesses. 8. Vergleich aktueller Reinigungsaufwände (2 min) – Key figures from pages 15–16 (Reaktoren up to 10 days cleaning, high water/solvent use). 9. Technische & GMP-Rahmenbedingungen (1:30 min) – Pressure limits (0.2/0.5 bar), ATEX considerations, QA/QS roles. 10. Pilotversuche & Ergebnisse (3 min) – Pilot tests with 100 L ARG and 100 L reactor; reproducible, visually clean results; identified parameters. 11. Change Control & Beschaffung (1 min) – Change control initiated, small qualification effort, ATEX safety considerations. 12. Reflexion (1 min) – CIP efficiency gains, PDCA value, learning outcomes. 13. Schlusswort (0:30 min) – Standardization contribution, continuation and rollout basis. Design: Corporate blue/white theme, clean layout, professional fonts, use icons for PDCA, SMART, and GMP topics.

This corporate presentation outlines the introduction of standardized CIP systems at Carbogen Amcis AG's Neuland site to optimize API manufacturing cleaning. It covers context, manual cleaning challen

December 2, 202513 slides
Slide 1 of 13

Slide 1 - Optimierung der Reinigungen durch Einführung von CIP-Systemen

The title slide is titled "Optimierung der Reinigungen durch Einführung von CIP-Systemen," which translates to optimizing cleaning processes through the introduction of CIP systems. It includes a subtitle crediting Mady Berthe, dated 2025, and associated with Produktion Neuland.

Optimierung der Reinigungen durch Einführung von CIP-Systemen

Mady Berthe | 2025 | Produktion Neuland

Source: Thesis cover page

Speaker Notes
Project title: Optimierung der Reinigungen durch Einführung von CIP-Systemen. Name: Mady Berthe, Date: 2025, Department: Produktion Neuland. Include image from cover page. Timing: 0:30 min
Slide 1 - Optimierung der Reinigungen durch Einführung von CIP-Systemen
Slide 2 of 13

Slide 2 - Einleitung & Kontext

Carbogen Amcis AG is a global CDMO focused on high-quality API development and manufacturing, adhering to strict GMP standards for safety and regulatory compliance. The Neuland site in Switzerland features advanced infrastructure and utilizes mobile equipment for efficient cleaning and maintenance.

Einleitung & Kontext

  • Carbogen Amcis AG: Global CDMO specializing in API development and production
  • API Manufacturing: High-quality synthesis for pharmaceutical active ingredients
  • GMP Requirements: Strict standards ensuring product safety and regulatory compliance
  • Neuland Site: Dedicated production facility with advanced infrastructure in Switzerland
  • Mobile Equipment Use: Flexible deployment for efficient cleaning and maintenance tasks
Slide 2 - Einleitung & Kontext
Slide 3 of 13

Slide 3 - Problemstellung

The slide titled "Problemstellung" highlights key challenges in manual equipment cleaning, including its time- and resource-intensive nature, high consumption of solvents and water, and difficulties with complex geometries. It also addresses issues like disassembly and reassembly efforts, risks of over-cleaning leading to material damage, and examples of unresolved solid residues.

Problemstellung

  • Zeit- und ressourcenintensive manuelle Reinigung
  • Hoher Verbrauch von Lösemitteln und Wasser
  • Schwierige Geometrien bei Ausrüstung
  • Demontageprobleme und Montageaufwand
  • Risiko der Überreinigung und Materialschäden
  • Beispiel: Ungelöste Feststoffrückstände
Slide 3 - Problemstellung
Slide 4 of 13

Slide 4 - Zielsetzung

The slide outlines the main objective of introducing a standardized, transferable CIP concept. It further specifies SMART goals focused on standardizing cleaning processes, reducing waste and resource consumption, enhancing occupational safety, and ensuring GMP compliance.

Zielsetzung

  • Hauptziel: Einführung standardisierten, übertragbaren CIP-Konzepts
  • SMART-Ziel: Standardisierung der Reinigungsprozesse
  • SMART-Ziel: Reduktion von Abfall und Ressourcenverbrauch
  • SMART-Ziel: Steigerung der Arbeitssicherheit
  • SMART-Ziel: Sicherstellung der GMP-Konformität

Source: Thesis: Optimierung der Reinigungen durch Einführung von CIP-Systemen by Mady Berthe (Carbogen Amcis AG, 2025)

Speaker Notes
Timing: 2 min. Explain main goal and SMART objectives, emphasizing benefits for standardization and efficiency.
Slide 4 - Zielsetzung
Slide 5 of 13

Slide 5 - Projektorganisation

The left column of the slide outlines key roles and departments in the project organization: Production leads cleaning processes and pilot tests, QA/QS ensures GMP compliance and validation, MAI/Engineering develops technical solutions and CIP systems, and ESH oversees safety and environmental aspects including ATEX. The right column describes an interface diagram (on page 8) illustrating departmental interactions, such as Production coordinating with Engineering for system integration, QA/QS checking GMP elements, ESH incorporating safety protocols, all connected by central project management for efficient CIP implementation.

Projektorganisation

Rollen und AbteilungenSchnittstellendiagramm (S. 8)
Produktion: Leitet Reinigungsprozesse und Pilotversuche. QA/QS: Gewährleistet GMP-Konformität und Validierung. MAI/Engineering: Entwickelt technische Lösungen und CIP-Systeme. ESH: Überwacht Sicherheits- und Umweltaspekte, inklusive ATEX.Das Diagramm zeigt Schnittstellen zwischen Abteilungen: Produktion koordiniert mit Engineering für Systemintegration, QA/QS prüft GMP-Aspekte, ESH integriert Sicherheitsprotokolle. Zentrale Projektleitung verbindet alle für effiziente CIP-Einführung.

Source: Thesis 'Optimierung der Reinigungen durch Einführung von CIP-Systemen' by Mady Berthe (Carbogen Amcis AG, 2025)

Speaker Notes
Present the key roles involved in the project and describe the interface diagram from page 8, highlighting cross-departmental collaborations for CIP implementation. Allocate 1:30 minutes.
Slide 5 - Projektorganisation
Slide 6 of 13

Slide 6 - Vorgehen (PDCA-Zyklus)

The agenda slide outlines the PDCA cycle approach for a project or process. It covers PLAN (conducting analysis and risk assessment), DO (starting pilot setup and implementation), CHECK (validating tests and evaluations), and ACT (creating SOPs and planning rollout).

Vorgehen (PDCA-Zyklus)

  1. PLAN

    2. Analyse und Risikobewertung durchführen

  2. DO

    3. Pilotaufbau und Umsetzung starten

  3. CHECK

    4. Tests und Evaluation validieren

  4. ACT

SOPs erstellen und Rollout planen Source: Thesis: 'Optimierung der Reinigungen durch Einführung von CIP-Systemen' by Mady Berthe (Carbogen Amcis AG, 2025)

Speaker Notes
Icons für PDCA-Schritte. (Timing: 2:30 min)
Slide 6 - Vorgehen (PDCA-Zyklus)
Slide 7 of 13

Slide 7 - Situationsanalyse & Reinigungsarten

The slide analyzes cleaning situations and types in industrial processes, detailing Primärreinigung (PR) as initial manual cleaning that's highly solvent- and time-intensive, Zwischenreinigung (ZR) as intermediate batch rinsing that inadequately removes residues in complex geometries, and Sekundärreinigung (SR) as final disassembly with risks of overcleaning and incomplete solids removal. It highlights common weaknesses, including labor-intensive and resource-heavy methods, as well as inefficiencies from difficult access points.

Situationsanalyse & Reinigungsarten

  • Primärreinigung (PR): Initial manual cleaning; high solvent and time consumption.
  • Zwischenreinigung (ZR): Intermediate batch rinse; inadequate residue removal in geometries.
  • Sekundärreinigung (SR): Final disassembly process; risks overcleaning and incomplete solids elimination.
  • Common weaknesses: Labor-intensive, resource-heavy; difficult access leads to inefficiencies.

Source: Optimierung der Reinigungen durch Einführung von CIP-Systemen by Mady Berthe (Carbogen Amcis AG, 2025)

Speaker Notes
Reinigungsarten PR, ZR, SR und deren Schwächen. (Timing: 2 min)
Slide 7 - Situationsanalyse & Reinigungsarten
Slide 8 of 13

Slide 8 - Vergleich aktueller Reinigungsaufwände

The slide compares current cleaning efforts for reactors, highlighting a maximum of 10 days required for manual cleaning processes. It also notes high resource consumption, including 5000 liters of water and 2000 liters of solvents per cycle in these methods.

Vergleich aktueller Reinigungsaufwände

  • 10: Days for Reactor Cleaning

    • Maximum duration for manual cleaning processes

  • 5000: Liters Water per Cycle

    • High consumption in current manual methods

  • 2000: Liters Solvents per Cycle

Significant solvent usage for thorough cleaning Source: Thesis by Mady Berthe, pp. 15–16

Speaker Notes
Highlight key figures on cleaning times and resource use for reactors; compare via diagrams. Timing: 2 min.
Slide 8 - Vergleich aktueller Reinigungsaufwände
Slide 9 of 13

Slide 9 - Technische & GMP-Rahmenbedingungen

The slide outlines key technical and GMP framework conditions, including standard and specific pressure limits of 0.2 bar and 0.5 bar, respectively, along with ATEX considerations for explosion-protected zones. It also covers the roles of QA/QS in validation and GMP compliance, plus technical requirements for CIP integration.

Technische & GMP-Rahmenbedingungen

  • Druckgrenzen: 0.2 bar Standard, 0.5 bar spezifisch
  • ATEX-Berücksichtigungen für explosionsgeschützte Zonen
  • Rollen von QA/QS: Validierung und GMP-Konformität
  • Technische Rahmenbedingungen für CIP-Integration

Source: Thesis 'Optimierung der Reinigungen durch Einführung von CIP-Systemen' by Mady Berthe (Carbogen Amcis AG, 2025)

Speaker Notes
Druckgrenzen (0.2/0.5 bar), ATEX-Berücksichtigungen, Rollen von QA/QS. GMP-Icons. (Timing: 1:30 min)
Slide 9 - Technische & GMP-Rahmenbedingungen
Slide 10 of 13

Slide 10 - Pilotversuche & Ergebnisse

Pilot tests were conducted using 100 L ARG and 100 L reactor setups to systematically optimize cleaning processes, focusing on pressure, temperature, and cleaning agents, with the goal of standardizing and ensuring transferability. The results achieved reproducible, visually clean outcomes with no residues, identifying key parameters such as optimal cycle times, pressure limits (0.2-0.5 bar), and solvent usage for efficient CIP applications.

Pilotversuche & Ergebnisse

Pilot-TestsErgebnisse
Durchgeführt mit 100 L ARG und 100 L Reaktor. Systematische Tests zur Optimierung von Reinigungsprozessen unter Berücksichtigung von Druck, Temperatur und Reinigungsmitteln. Ziel: Standardisierung und Transferierbarkeit.Reproduzierbare und visuell saubere Ergebnisse erzielt. Keine Rückstände nach Reinigung. Identifizierte Schlüsselpparameter: Optimale Zykluszeiten, Druckgrenzen (0.2-0.5 bar) und Lösungsmittelverbrauch für effiziente CIP-Anwendung.
Speaker Notes
Pilot-Tests with 100 L ARG and 100 L reactor; reproducible, visually clean results; identified parameters. (Timing: 3 min)
Slide 10 - Pilotversuche & Ergebnisse
Slide 11 of 13

Slide 11 - Change Control & Beschaffung

The slide outlines the Change Control process for implementing CIP, highlighting low qualification efforts through a standardized approach and minimal validation needs for efficiency gains. It also covers integrating ATEX safety aspects into procurement and focusing on compliance when acquiring CIP components.

Change Control & Beschaffung

  • Change Control process initiated for CIP implementation
  • Low qualification effort due to standardized approach
  • ATEX safety aspects integrated in procurement
  • Procurement of CIP components with compliance focus
  • Minimal validation required for efficiency gains
Speaker Notes
Change Control eingeleitet, geringer Qualifikationsaufwand, ATEX-Sicherheitsaspekte. (Timing: 1 min)
Slide 11 - Change Control & Beschaffung
Slide 12 of 13

Slide 12 - Reflexion

The Reflexion slide highlights significant efficiency gains achieved through the introduction of CIP processes, alongside proven benefits of the PDCA cycle as a framework for project management and the identification of key learning outcomes for future optimizations. It also emphasizes reductions in cleaning efforts and resource use, while ensuring improved safety and GMP compliance.

Reflexion

  • Erhebliche Effizienzgewinne durch CIP-Einführung erzielt
  • PDCA-Zyklus als wertvolles Framework für Projektsteuerung bewährt
  • Wichtige Lernerfolge für zukünftige Optimierungen identifiziert
  • Reduzierter Reinigungsaufwand und Ressourcennutzung erreicht
  • Verbesserte Sicherheit und GMP-Konformität gesichert

Source: Thesis: Optimierung der Reinigungen durch Einführung von CIP-Systemen by Mady Berthe

Speaker Notes
Effizienzgewinne durch CIP, Wert des PDCA, Lernerfolge. (Timing: 1 min)
Slide 12 - Reflexion
Slide 13 of 13

Slide 13 - Schlusswort

The slide's main text emphasizes the contribution to standardization as a foundation for rollout. Its subtitle calls for collaborative implementation of the CIP rollout.

Schlusswort

Beitrag zur Standardisierung – Basis für Rollout.

Gemeinsam den CIP-Rollout umsetzen!

Source: Thesis: Optimierung der Reinigungen durch Einführung von CIP-Systemen, Mady Berthe, Carbogen Amcis AG, 2025

Speaker Notes
Beitrag zur Standardisierung, Basis für Fortsetzung und Rollout. (Timing: 0:30 min)
Slide 13 - Schlusswort

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