"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"

Compliance Seminars®

Biocleaning: Cleaning and decontamination of surfaces

in cleanrooms and apparatus


Course objectives

  • Better understanding of the GMP context to clean and disinfect premises and non critical surfaces in classified areas and apparatus.
  • Master the choice of methods to put in place and adapt them to GMP requirements.
  • Design a Biocleaning program adapted to premises and its activities.
  • Give innovative practices in order to put in place practical methods.

Who should attend:

This training is intended to Managers and Operators in charge of Disinfection operations in cleanrooms : Quality Support, Production and Sterility Assurance Departments.

Course content:

  • European and American Regulations:
    • “Part I Chapter 3 – Premise and Equipment”
    • “Part I Chapter 5 - Production”
    • “Annex 1 Manufacture of Sterile Medicinal Products”, New draft February 2020
    • FDA “Guidance for Industry Sterile Drug Products Produced by Aseptic processing – Current Good Manufacturing Practice (September 2004)”
    • PDA “Technical Report No.70 Fundamentals of cleaning and Disinfection Programs for Aseptic Manufacturing Facilities”
  • Contaminants to eliminate:
    • Cross Contamination, Chemical residuals of ancillary products ((detergents, disinfectants, …)., Particles, Microorganisms.
  • The different steps of a Biocleaning program:
    • Disposal of visible waste
    • Dusting (wet sweeping and wet wiping)
    • Detergency
    • Disposal of soiled solution
    • Disinfection
  • Good practices of Biocleaning:
    • Feedback on actual cases
  • Characteristics of different tools and storage conditions in production:
    • Wipes, brooms,…
  • Quality Assurance and Biocleaning:
    • The different documents needed and example of an audit tool
  • Disinfection by air:
    • Hydrogen peroxide vapor techniques
  • Fumigation or vapour disinfection (e.g. Vapour-phased Hydrogen Peroxide) of cleanrooms
  • Practices after a shutdown

  • Validation of Disinfection in according with the Annex 15:
    • Validation studies should demonstrate the suitability and effectiveness of disinfectants in the specific manner

 

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Course facts

Course no:
5125
Industry:
Pharmaceuticals

Level:
Intermediate
GMP region:
US and EU

Language:
English

Instructors:
Pierre Devaux  Elodie Pastre
Pierre Devaux and Elodie Pastre, Theraxel - Point Forty Five

Date, location and venue:

15 December, Amsterdam
Double Tree Hilton, Centraal Station
Oosterdoksstraat 4    

Register by 3 November - Save € 100

This course is offered in-house.
Click here for more info and inquiry form.


Time:
1 day
9.00-16.30 (Registration 08.30-09.00)

Price (excl. local VAT):
Register up to 3 Nov - save € 100
Until 3 Nov: € 950
From 4 Nov:€ 1 050
incl. course material (pdf), lunch and refreshments

Note. Due to tax/VAT regulations within the EU (for courses/seminars/conferences), the course fee is invoiced in the local currency and local VAT is added.
Accommodation is NOT included in the course fee.

Discounts:
For groups registered and invoiced together for the same course we offer the following quantity discount:
3 persons or more 15%
We do not offer or practice any general company discounts without commitments and/or written agreements.


Course material (Handouts)  
No printed course material will be provided on our courses*.
This is primarily to protect the environment. Therefore, we encourage you to bring a laptop / tablet to the course - it is possible to make notes in the PDF file you will have access to.
3-5 days prior the course you will receive a download link for the course handouts as a PDF.
Note pads and pens will always be provided at the venue.

Cancellation policy - Compliance Seminars®  

Cancellation of registration:

Registration is binding and when you have received our confirmation the following conditions are known and accepted. If you for any reason is unable to attend, substitution is always possible and preferred.
All cancellations and/or substitutions must have been communicated with and confirmed by us.
Cancellations received less than 30 calendar days before course start are subjected to a service charge of 150 € (Euro)/registered course day as compensation for additional administrative burden and for non refundable part of the conference reservation. Cancellations received less than 14 calendar days prior the course, or failure to cancel or "no-show", will be charged in full.

Cancellation of courses: Courses may be cancelled by the organizer if bookings fail to reach minimum numbers (normally not later than 30 days prior the course start), or due to other reasons beyond our control. In such circumstances charged course fees will be refunded, credited, or granted to attend another course for the same value. NOTE! Key2Compliance AB is NOT responsible or liable to any costs in conjunction with a cancelled course. If you need to book flights way ahead (+35 days prior the course) check with us before finalizing the purchase of flights and/or hotel accommodation for an update on the registration situation.