Sustainability Water Clinic

Chatroom Hosted & Sponsored by:

Synopsis: Water treatment and compliance if done properly need not be costly and nerve wrecking. In this Water Sustainability Clinic, Veolia water experts will offer some tips and advice on how to tackle challenges in every phase of your water cycle from compendial validated water to effluent treatment. Below are some topics covered, however, you are welcome to seek consultation on any challenges you may have.

Discussion Takeaways:

• Optimizing energy consumption in your water cycle
• Ensuring consistent microbial compliance
• Performing beyond local discharge standards on EDCs and PPCPs

Expert Host:

Kok Fong TIYO, Market Manager, Pharmaceuticals & Healthcare, Asia, Pacific, Veolia Water Technologies

Joined Veolia Water Technologies in 2012, Kok Fong has since handled various portfolios within the organization. Based in Singapore, Kok Fong holds a degree in Chemical-Bioprocess Engineering. He can be contacted at kokfong.tiyo@veolia.com

Best safety from endotoxins in pharmaceutical water & Reducing HVAC energy consumption

Chatroom hosted by REPASSA with technical experts from BWT & Telstar

Sponsored by:

Synopsis (HVAC) : The challenge of reducing HVAC energy consumption and operation costs without negatively affecting the quality of the finished products, ensuring cleanrooms always conform to required specifications

The SmartCR is an innovative flexible solution for cleanrooms that adjusts air changes which reduces energy consumption and operation costs, ensuring cleanrooms always conform to required specifications. The adjustment is done through the HVAC control system, considering inline particle counters, differential pressure transmitters and temperature and relative humidity probes.

Synopsis (Endotoxin) : Endotoxins are the most potent exogenous pyrogens. Even very small amount can cause excessive activation with consequences like high fever, drop in blood pressure, clot formation in the capillaries and multi-organ failure. Due this clinical significance, the contamination of pharmaceutical preparations and medical devices must be avoided at all costs. The pharmacopoeias as Ph. Eur., USP, JP and CP state clear limit values for Endotoxin Units. In this topic we enlighten how to limit the risk in pharmaceutical water systems (critical utilities) to the absolute minimum, either by use of thermal distillation systems or environmental friendly and cost-effective membrane-based solutions and the right storage and distribution solution to maintain that quality level. All this is backed up and concluded with figures from studies and systems from practical experience.

Discussion Takeaways:

• Why are endotoxins a risk
• What do the applicable regulations say.
• Then we look at the technology: Which processes are best suited to remove endotoxins beyond the required level in a permanent and safe way.
• Finally, we look at the practice: What are the experiences – which solutions have proven to be reliable and what do we have to pay more attention to?
• At the end of the day participants have a checklist with 5 points for safety from endotoxins.

Expert Hosts:

Ana Fernández García, Pharmaceutical Technology Manager, Telstar’s CRS Engineering

Ana holds a MEng in Industrial Engineering from the UPM (Madrid, Spain) together with a MEng in Chemical Engineering from CPE (Lyon, France). After some years working in the Pharmaceutical industry, Ana joined the Engineering Department at Telstar in 2007, participating in and managing a wide variety of cleanroom engineering, construction and turnkey projects. Since 2017, Ana is in charge of Conceptual Designs.

Francesc Tarrats Galocha, CRS Cleanroom Engineer, Telstar’s CRS Engineering

Francesc holds a BEng in Mechanical Engineering from the UPC (Barcelona). After a year working as a Control Engineer for HVAC and Process pharmaceutical facilities, Francesc joined the company in 2015 taking part in a variety of cleanroom engineering and construction projects.

Best safety from endotoxins in pharmaceutical water

Chatroom hosted by REPASSA with technical experts from BWT

Sponsored by:

Expert Hosts:
Philipp Ettle (Water Expert)

Philipp holds an M.Sc. in Bioprocess Engineering which he graduated from the University of Applied Science in Mannheim.

He spent the first years of his career with a large multinational pharmaceutical engineering company and successfully supported demanding multinational customers in the areas of utilities and process technology. In 2015 he joined BWT and started at the project management team for critical utilities and managed several large greenfield and brownfield projects. Since 2 years ago, he is the sales director and supports with his team customers in Germany, Southeastern Europe, South America, Middle East and Southeast Asia.

Thomas Killinger (Water Expert)
Thomas is a specialist for clean media in pharma & biotech and has been working for BWT for over 25 years.

As a technical expert for membrane and distillation processes, storage, distribution and automation, he spends most of the year in South East Asia on behalf of customers. Due to his expertise, he has a dual role at BWT as a service technician and sales manager, advising customers in all aspects.

Solution Provider for the Pharmaceutical Industry

Chatroom Hosted & Sponsored by:

Expert Host:
Pierre Winnepenninckx, CEO, No deviation

Pierre is a Chemical Engineer and the CEO of No deviation. He likes to develop a team vision for quality accountability and innovation. He is hugely optimistic and sees the opportunity in every task he undertakes.

Cleaning and Disinfection in Cleanroom

Chatroom Hosted & Sponsored by:

Synopsis: The cleaning and disinfection program’s purpose is to prevent microbial contamination of the cGMP environment and the product.

Consequently, a pivotal element to contamination control risk assessment is to define the source of contamination. Based on the risk assessment results, appropriate cleaning and disinfection procedures and controls to prevent contamination must be identified.

The goal of this discussion is to present best practices around cleaning and disinfection procedures to prevent microbial contamination in the cleanroom.

Discussion Takeaways:

• Learn the current best practices regarding cleaning and disinfection of hoods, RABS and Isolators.
• Understand the regulatory requirements and the potential impact of the draft Annex 1 revision in cleaning and disinfection program for cleanroom.
• Learn from case study to convey industry best practices.

Expert Host:
Richard Chai, Technical Service Manager, STERIS Corporation

As a Technical Service Manager in the Life Sciences Division of STERIS Corporation, he has been providing global technical support related to cleaning and bioburden control for cleanrooms, including disinfectant validation, as well as cleaning validation for product contact surfaces.

Prior to joining STERIS, he has 16 years of manufacturing, validation and consultancy experience working in dry powder inhaler plant, biotech sterile fill and finish plant, medical device and biopharmaceutical facilities. He have also published articles and book chapter in contamination control, and is a frequent industry speaker at industry events such as ISPE and PDA.