Environmental Monitoring in the Pharmaceutical Sector

  • 1° EDITION: 22 May 2024
  • 2° EDITION: 19 March 2025
  • Online
  • Italian

Training overview

Production sites and processes are changing rapidly to adapt to the increasingly stringent requests of regulatory bodies which push towards the use of safer technologies.

One of the focal points of the new Annex 1 will be the push towards the implementation of more modern technologies “Barrier systems however must be properly designed, decontaminated, operated and maintained in order to ensure effective contamination control”. Many companies need to innovate and optimize to be compliant with increasingly challenging regulatory requirements. PEC, on this day, wants to address the topic in question, with a practical and experience slant, offering a technical insight into the 2 technologies most widespread today in the production of tailings, comparing their strengths and weaknesses, in order to know how to manage them the best way to achieve and maintain the Sterility Assurance of the product. Spekaers will help you clarify doubts by answering practical questions in an enriching exchange.

Key points of the training

  • The regulatory requirements related to Environmental Monitoring
  • The sampling methods and techniques, and how to validate them
  • Perform microbiological and particulate validation of environments
  • Have the opportunity to discuss and clarify doubts with experts.

09:30 – 12:30 MORNING SESSION
14:00 – 17:00 AFTERNOON SESSION

RABS – MORNING SESSION

Patrizia Muscas, Sterility Assurance Senior Consultant – Eli Lilly Italy

  • Strengths of RABS technology
  • Critical points to consider when choosing the technology:

– functionality, safety, compliance, maintenance, costs, versatility

  • Criteria for choosing the number/position of glove accesses
  • Classification and Monitoring:

– normative requirements
– choice of points
– technologies (alternative systems-potential)

  • RABS gloves:
    – choice of points
    – typologies
    – certification
    – microbiological checks

– Integrity testing
– replacement frequencies

  • RABS sanitization:
    – frequencies
    – choice of reagents
  • Validation Highlights:
    – Smoke test
    – medium fill
    – operator validation
    – types of interventions grade A/B, material handling from class B within the RABS
  • Cases of out-of-bounds deviation and approaches to their management

 

ISOLATOR – AFTERNOON SESSION

Andrea Pranti, Qualification Transformation Engineering Manager – GSK Vaccines – Siena

  • Strengths of the Isolator technology and types:

– functionality, safety, compliance, maintenance, costs, versatility

  • Material introduction and outfeed systems: IN and OUT ports
  • Classification and Monitoring:

– normative requirements
– choice of points
– technologies (systems – alternative potential)

  • Isolator Gloves:

– choice of points
– typologies
– certification
– microbiological checks
– integrity tests
– replacement frequencies

  • Biodecontamination: modalities and problems
  • Validation Highlights:

– smoke test
– medium fill
– operator validation

  • Cases of out-of-bounds deviation and approaches to their management

Sterility Assurance Manager, QP, Quality Operations, Microbiology Manager, Maintenance and Engineering Manager, Production Manager.

The course will be carried out through live lectures. Practical examples will be showcased, providing delegates with real life examples to be applied in their daily job life.

For online trainings the access link will be sent 2-3 days before the start of the training.

5% discount for registrations within 1 month before the start of the training, 10% discount for registrations within 2 months before the start of the training. VAT not included. Please inquire for discounts for multiple registrations. Discounts are not cumulative.

Cancellation terms

In order to cancel enrolment to an event, please email info@pharmaeducationcenter.it within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.

Participant replacement

It is possible to replace a participant attendance without additional cost, simply by contacting info@pharmaeducationcenter.it. It is asked to notify the participant replacement request within 5 days before the starting date of the course/event, specifying the full name and surname of the enrolled participant as well as the full name and surname of the substitute.

Training cancellation

If the minimum number of participants is not reached, Pharma Education Center reserves the right to cancel or schedule the event for another date. Formal communication will be given within 5 days before the event date. In this case Pharma Education Center will refund the registration fee in full and without additional charges. Alternatively, the participant can request a spendable coupon for participating in another PEC event scheduled in the current year.

Speakers

Patrizia Muscas

Patrizia Muscas

Sterility Assurance Senior consultant at Eli Lilly

Sterility Assurance Senior consultant in Eli Lilly. 23 years of experience in Pharmaceutical and Biopharmaceutical field. Experience raised working with International Companies (GSK; Chiron Vaccine/Novartis; Eli Lilly). Good improvement for the quality and the efficiency of the Microbiological laboratory and Parenteral production. During these years of experience I have been part of different teams involved in the validation and improvement of production sites for Sterile liquids, Dry powders, Vaccines, and non-sterile products. The skills required for the positions covered has included: deep knowledge of Microbiology,Virology and Biotechnology; knowledge of all Microbiological, Biological and Immunological tests related to sterile drugs and vaccines as well as deep knowledge of applicable regulations including USP /EP /EMA/ISO/FDA cGMP’s. In the last 8 years my primary role was dedicated to oversight of all sterility assurance aspect/topics with regards to production isolator lines and new RABS line. I was part of the team involved in different isolator Lines Projects with responsibility for all Sterility Assurance topics/strategies and in particular on Isolator VPHP cycle and sterilization processes qualification/management. I’m currently the Leader of the team guarantying the oversight for all Sterility Assurance aspects of the Italian International Company Parenteral site and as part of this role there is the active participation to Global Network teams for all the aspects related to Sterility Assurance, Environmental Monitoring.

Andrea Pranti

Andrea Pranti

Qualification Transformation Engineering Manager at GSK Vaccines

Graduated in Industrial Chemistry and Biology at the University of Siena, he began his working career at ENI and Solmine in June 1988 as supervisor of the chemical laboratory and raw materials specialist. He began his work experience in Sclavo/Chiron – Vaccines (now Novartis VND) in July 1996, as “Quality assurance expert”. In this position (from 1996 to 2001) Pranti deepened his experience on aseptic processes (formulation, filling and inspection of vaccines in liquid and freeze-dried form) and packaging for commercial production (with management of deviations, change, SAP, LIMS and batch record review). From 2001 to July 2007, he was “Senior Specialist” for a project to implement a new department dedicated to aseptic activities, deepening in this position the skills related to engineering and validation aspects (FAT, SAT,), problem solving and to the Quality and Compliance aspects of aseptic activities. From 2007 to today, he has been working in the Product Assurance Aseptic Process sector as a manager with qualitative responsibilities related to the aseptic area for the new NVD Department, coordinating a team of 24 people. Over the years, Pranti has gained in-depth experience in continuous improvement, problem solving, team management, quality risk management, sterility assurance and GMP compliance aspects.

Register now

Early Bird 10%
Within 2 months before the start of the training
765€
850€
Early Bird 5%
Within 1 month before the start of the training
805€
850€
Full price

850€

Training materials available for attendees

Certificate of attendance

Senior trainers with hands-on experience

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