Bioburden Control Processes
Bioburden Control Processes

Course Description

In difference to Aseptic processing that applies to finished sterile products this course has a focus on Bioburden control applied to manufacture of biological intermediates, Drug substances (including vectors), APIs and non-sterile products that benefit (patients) from bioburden control. Annex 1 revision 2023 has an extended scope covering bioburden control processes. USP<1115> outlines the factors and influences of bioburden in facilities and processes. As regulations and guidance’s change it is important to understand regulatory expectations and principles to follow that contribute to assured ‘product’ quality at a defined and specified level.

A sites ‘product’ may not be the final finished product but an essential component or entity of a sterile product and typically subjected to manufacturing at different sites in dedicated facilities and/or completely separate to Fill and Finish activities. The quality oversight becomes more challenging as regulations are less specific and require interpretation.  Bioburden control can apply upstream and downstream to drug substance with different levels of acceptance and control. Learn about bioburden control in ‘Closed’ systems and where open interventions apply e.g. Seeding inoculation how bioburden control is applied.

Some bioburden is inherent and acceptable at specified (justified) levels but in all cases must meet a specified level or microbial flora profile so control is required. This course will consider regulatory expectation the application of the principles of Quality Risk Management (QRM) ICHQ9(R1) over the product Life Cycle (ICHQ12).

Bioburden control as with all contamination control is assured in the first instance by design that combines facility and process design with good procedural design. Annex 1 has a requirement for a CCS: Contamination control Strategy and it is considered such a strategy should also apply to bioburden control processes but at a level that is ‘Phase appropriate’ and commensurate to process knowledge, complexity and risks of harm to patients.  Learn about a CCS application for a bioburden control process and connection of the CCS to other Control strategies.

Bioburden in biological processes for manufacturing intermediates or substances can compromise the efficacy and mechanisms that apply to the advanced therapy or medicinal product as a component of a finished sterile product.  So risks from bioburden contamination are not entirely about compromise of sterility of final products. Oral solid dose forms, if contaminated with unacceptable bioburden can cause harm to patients, particularly those with compromised immune systems.

Bioburden matters so control is an essential part of processing/ manufacturing. Learn where, how and when control is applied.

  • The principles that apply to bioburden control in
    formulation of products and intermediates and through manufacturing facilities including closed system and open system processing
  • Bioburden control processes are in the scope of EU GMP & PICS Annex 1 and the impact of 2023 revision including requirements for a CCS: Contamination Control Strategy
  • Connection of control strategies covering CMC and GMP; including PCS: Product control strategies, CCS: Contamination control
    strategy, CCCS: Cross contamination control strategy and ACS: Aseptic containment strategy. CTD: Common Technical Document and adventitious agents (Module 3)
  • Bioburden control and designation of controlled
    areas, GMP grading and application of environmental monitoring
  • Revision of ICHQ9(R1) on Quality risk management and risk assessments for bioburden control processes with less subjectivity, as
    a key principle in the revision
  • Life cycle strategies following technical and
    regulatory considerations set out in ICHQ12 and how this applies to bioburden control processes
  • Bioburden control in a Viral Vector manufacturing
    and formulation process
  • Bioburden control through a Biotech manufacturing process including upstream and downstream: Seeding, expansion, Buffer
    preparation, Bioreactors, Chromatography, Filtration, ‘Product’ filling into
    delivery containers
  • Bioburden control through API manufacturing,
    dispensing and charging to vessels/ reactors
  • Bioburden control for non-Sterile products
    including Oral Solid Dose forms (OSDs). What key GMP requirements apply
  • Discussion forum at close of each day of training
    covering open issues in bioburden control
  • Understand bioburden control connection of GMP - CMC and CTD
  • Bioburden profiles and importance of control for
    intermediates, substances, APIs and non-sterile products
  • Understand how to apply formality of QRM: ICHQ9(R1) through Bioburden control processes
  • Learn about a risk assessment model: FMECA suitable for bioburden control with less subjectivity as a key requirement of revised
    ICHQ9(R1)
  • Characterising a CCS: Contamination control
    strategy for a bioburden control process that applies over a product life cycle
  • Bioburden control; Material transfers (MALs)
    through GMP CNC, D into Grade C
  • Bioburden control and considerations in Closed and Open processing systems through interventions; sampling and in-process
    interventions
  • Key points to consider in bioburden control for a
    Biotech process involving upstream and downstream processing. Based on case study example
  • Key points to consider in bioburden control through formulation of a sterile product, up to where PUPSIT applies for product sterilisation by filtration
  • Key points to consider for bioburden control in
    viral vector substance processing. Based on Case study example
  • Bench mark bioburden control approaches in a
    discussion forum

Bioburden Control Processes

New Dates TBA, Live Online Training
Regular price €1.850,00
Unit price
per 
James L. Drinkwater

James L. Drinkwater is the current Head of GMP Compliance at Franz Ziel Germany. James is based in the UK for the global role and separately supports the Not-for-profit society: Pharmaceutical and Healthcare Sciences Society: PHSS an educational platform in GxP. James is the ex-Chairman (10 years) of the PHSS and currently Co-leads the Annex 1 and CCS Guidance focus groups.

START TIMES

1:30 PM Vienna time

12:30 AM London time

7:30 AM New York time

Group discounts available upon request - contact us.

100% Secure payments

Your details are protected and safe with us. Taxes calculated at the checkout.

American Express
Mastercard
Visa

Course Description

In difference to Aseptic processing that applies to finished sterile products this course has a focus on Bioburden control applied to manufacture of biological intermediates, Drug substances (including vectors), APIs and non-sterile products that benefit (patients) from bioburden control. Annex 1 revision 2023 has an extended scope covering bioburden control processes. USP<1115> outlines the factors and influences of bioburden in facilities and processes. As regulations and guidance’s change it is important to understand regulatory expectations and principles to follow that contribute to assured ‘product’ quality at a defined and specified level.

A sites ‘product’ may not be the final finished product but an essential component or entity of a sterile product and typically subjected to manufacturing at different sites in dedicated facilities and/or completely separate to Fill and Finish activities. The quality oversight becomes more challenging as regulations are less specific and require interpretation.  Bioburden control can apply upstream and downstream to drug substance with different levels of acceptance and control. Learn about bioburden control in ‘Closed’ systems and where open interventions apply e.g. Seeding inoculation how bioburden control is applied.

Some bioburden is inherent and acceptable at specified (justified) levels but in all cases must meet a specified level or microbial flora profile so control is required. This course will consider regulatory expectation the application of the principles of Quality Risk Management (QRM) ICHQ9(R1) over the product Life Cycle (ICHQ12).

Bioburden control as with all contamination control is assured in the first instance by design that combines facility and process design with good procedural design. Annex 1 has a requirement for a CCS: Contamination control Strategy and it is considered such a strategy should also apply to bioburden control processes but at a level that is ‘Phase appropriate’ and commensurate to process knowledge, complexity and risks of harm to patients.  Learn about a CCS application for a bioburden control process and connection of the CCS to other Control strategies.

Bioburden in biological processes for manufacturing intermediates or substances can compromise the efficacy and mechanisms that apply to the advanced therapy or medicinal product as a component of a finished sterile product.  So risks from bioburden contamination are not entirely about compromise of sterility of final products. Oral solid dose forms, if contaminated with unacceptable bioburden can cause harm to patients, particularly those with compromised immune systems.

Bioburden matters so control is an essential part of processing/ manufacturing. Learn where, how and when control is applied.

  • The principles that apply to bioburden control in
    formulation of products and intermediates and through manufacturing facilities including closed system and open system processing
  • Bioburden control processes are in the scope of EU GMP & PICS Annex 1 and the impact of 2023 revision including requirements for a CCS: Contamination Control Strategy
  • Connection of control strategies covering CMC and GMP; including PCS: Product control strategies, CCS: Contamination control
    strategy, CCCS: Cross contamination control strategy and ACS: Aseptic containment strategy. CTD: Common Technical Document and adventitious agents (Module 3)
  • Bioburden control and designation of controlled
    areas, GMP grading and application of environmental monitoring
  • Revision of ICHQ9(R1) on Quality risk management and risk assessments for bioburden control processes with less subjectivity, as
    a key principle in the revision
  • Life cycle strategies following technical and
    regulatory considerations set out in ICHQ12 and how this applies to bioburden control processes
  • Bioburden control in a Viral Vector manufacturing
    and formulation process
  • Bioburden control through a Biotech manufacturing process including upstream and downstream: Seeding, expansion, Buffer
    preparation, Bioreactors, Chromatography, Filtration, ‘Product’ filling into
    delivery containers
  • Bioburden control through API manufacturing,
    dispensing and charging to vessels/ reactors
  • Bioburden control for non-Sterile products
    including Oral Solid Dose forms (OSDs). What key GMP requirements apply
  • Discussion forum at close of each day of training
    covering open issues in bioburden control
  • Understand bioburden control connection of GMP - CMC and CTD
  • Bioburden profiles and importance of control for
    intermediates, substances, APIs and non-sterile products
  • Understand how to apply formality of QRM: ICHQ9(R1) through Bioburden control processes
  • Learn about a risk assessment model: FMECA suitable for bioburden control with less subjectivity as a key requirement of revised
    ICHQ9(R1)
  • Characterising a CCS: Contamination control
    strategy for a bioburden control process that applies over a product life cycle
  • Bioburden control; Material transfers (MALs)
    through GMP CNC, D into Grade C
  • Bioburden control and considerations in Closed and Open processing systems through interventions; sampling and in-process
    interventions
  • Key points to consider in bioburden control for a
    Biotech process involving upstream and downstream processing. Based on case study example
  • Key points to consider in bioburden control through formulation of a sterile product, up to where PUPSIT applies for product sterilisation by filtration
  • Key points to consider for bioburden control in
    viral vector substance processing. Based on Case study example
  • Bench mark bioburden control approaches in a
    discussion forum

"Trainer is very competent and has the complete knowledge of the matter."

– Senior Process Expert, B. Braun

"It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."

– Tech Transfer Lead, Novartis

"Thank you for sharing all the links and informative material. Very professional organization and execution."

– Manufacturing Manager, Thermo Fisher Scientific

"The trainer was very knowledgeable about the topics and was able to answer all questions."

– Drug Product Subject Matter Expert, Pfizer

"Excellent work of the lecturer, good materials, clear explanations."

– Clinical Pharmacologist, Boehringer Ingelheim

Bioburden Control Processes

Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.

Medical-Devices-Certificate-Course

In-house Training

Looking for tailored training solution?

All of our pharma & biotech training courses can be delivered at your company premises at a time that suits you. If you can not find what you are looking for in our public training offering, our trainers and producers will develop bespoke programmes to address your training needs.