Spray Drying With Guided Tour at the Hovione Site (without workshop)

7-9 June 2016, Lisbon, Portugal

Course No. 15150

header-image

Speakers

Dr Sune Klint Andersen, Novo Nordisk, Denmark
Dr Rui Ferreira, Hovione, Portugal
Dr Filipa Maia, Hovione, Portugal
Dr Ulrich Meier, Novartis, Switzerland
Dr Thomas Quinten, Janssen Pharmaceutica, Belgium
Henrik Schwartzbach, GEA, Denmark
Dr Harald Stahl, GEA, Germany
Dr Joao Vicente, Hovione, Portugal

Objectives

Take advantage of the opportunity to focus on spray drying technology and process and get a first hand demonstration of solutions for diverse requirements. Further, benefit from the post-conference session where you can get a hands-on experience in spray drying yourself. You will learn in small groups how the spray drying result is affected by different equipment, parameter changes, solvents etc.

Background

Spray drying is presently one of the most exciting technologies for the pharmaceutical industry, being an ideal process where the end-product must comply with precise quality standards regarding particle size distribution, residual moisture/solvent content, bulk density and morphology.

One advantage of spray drying is the remarkable versatility of the technology, evident when analysing the multiple applications and the wide range of products that can be obtained. From very fine particles for pulmonary delivery to big agglomerated powders for oral dosages, from amorphous to crystalline products and the potential for one-step formulations, spray drying offers multiple opportunities that no other single drying technology can claim.

Benefits of Spray Drying
High precision control over:
Particle size
Bulk density
Degree of crystallinity
OVIs and residual solvents
Typical application in pre-formulated products
Microencapsulations
Solid solutions
Improved bioavailability and stability
For products with unusual or difficult characteristics
Sticky or hygroscopic products
Slowly crystallizing products
Difficult to isolate products
Rapid drying for temperature sensitive materials

Target Group

This conference addresses specialists and executives working in the fields of pharmaceutical manufacture, research and development and quality control as well as technicians, planners and plant designers, especially those involved with the manufacture of powders and granules, as e.g. in the manufacture of solid dosage forms for oral or pulmonary administration.

Programme

Fundamentals of Spray Drying
Identification of Critical Process Parameters
Control of those Process Parameters
Influence of these Process Parameters on Product Quality
Example of setting up a Spray Drying Process

Spray drying from a particle perspective
Gas temperature and humidity
Drying at particle level
Stickiness (time, temperature and humidity)
CFD models and drying kinetic analysis

Spray Drying vs Freeze Drying – How to choose the right technique?
Fundamentals of Freeze Drying
Spray Drying of Pharmaceuticals
Formulation via spray drying
Scientific basics
Review of spray-dried pharmaceutical products
How to conclude: Spray Drying or Freeze Drying

Development of Scaleable Spray Drying Processes for Solid Drug Product Manufacture
The presentation starts from the target properties of pharmaceutical intermediates and products for oral solid dosage forms and for dry powder inhalation, viewing SD as a particle design tool. Examples of various product types, such as amorphous drug substances, solid dispersions, granulates and inhalable powder, are given. SD is then compared to other drying/ agglomeration processes more common in the pharma industry. A systematic approach for development of products/ processes by means of spray drying is illustrated, following the methodology proposed e.g. in a publication by Dobry et al. A special focus is given to the scaleability of the SD processes. Scale-up of pharma manufacturing processes asks some specific requirements from developers as well as from equipment to be used.

Validation and the usage of QbD for Spray Drying
Risk assessment in the context of qualification and validation
Development of spray drying process using DoE
Three stage DoE
Parameter screening (CCF design with 3 variables + extension)
Raw material variability
Process Validation
PAT: Inline particle sizing and NIR used to monitor the spray drying process
Special test during qualification and validation

Scale-up of a Spray Drying Process
The bench scale spray drying units can be found in most of the material characterisation and drug development teams, being also used as production units of high-value low-volume drugs. However, it is often underestimated the valuable information that lab experiments can give to help in a successful process scale-up. In this presentation a scale-up methodology will be presented where insight will be given on what and how lab scale data can be used, as well as, how scaling-up can be used to improve product properties.
Usage of lab scale data
Product improvement during scale up
Methodology for scale up of SD processes

Trouble Shooting Session
In this interactive session, all the key elements of the preceding lectures are brought
together. A systematic approach is presented and discussed with regards to the possible measures which could be taken:
What to do if:
Particles are too fine/coarse
Yield is too low
Final product moisture content is too high
Different product characteristics after scale up

Case study: Enhancing the bioavailability of poorly soluble drugs using spray drying: scaling up from lab scale to commercial scale
Short introduction on amorphous solid dispersions
Manufacturing technologies
Case study of itraconazole (Sporanox®)
Case study of etravirine (Intelence®)

Case study: Application of Spray Drying for oral dosage forms
Improving oral dosage forms performance through spray drying
Case-study 1 – Laboratory scale challenges
Focus on laboratory scale unit limitations
How to improve powder properties at laboratory scale
Strategies to formulate poor flowing SD powders

Case-study – Commercial challenges
Focus on adjusting powder properties for locked formulations
How to develop a commercial process
Strategies to cope with challenging targets (e.g. density, PS)

Case study: Application of Spray Drying for Inhalation Products
Introduction: applications of spray drying for inhalation products (carrier-based and
composite formulations)
Critical quality attributes: an overview for composite formulations via spray drying
Spray drying process: Thermodynamics aspects specific of Inhalation products
Spray drying process: Atomization aspects (controlling particle size and morphology)
Composite DPI formulations through spray drying

Site Visit at Hovione on Thursday, 9 June 2016
cGMP Spray Drying Equipment and Facility

Part of the programme on the third day of the conference is a guided tour at the Hovione site.

In line with the latest developments on spray drying technologies and with the increasing demand for highly defined particles properties in the pharmaceutical industry, Hovione has installed and commissioned a range of spray drying units able to operate under the most stringent cGMP conditions.

These laboratorial, pilot and industrial scale units allow Hovione to offer from a few grams to full scale commercial production. With FDA-inspected plants Hovione is capable to manufacture spray dried material under cGMP conditions.

The guided tour will include a visit of the spray dryer building where pilot, small and full commercial scale equipment can be seen. Moreover the production control room and the analytical labs will be part of the guided tour.

stop

This course is part of the GMP Certification Programme "ECA Certified Technical Operations Manager" Learn more

This training/webinar cannot be booked. Send us your inquiry by using the following contact form.

To find alternative dates for this training/webinar or similar events please see the complete list of all events.

For many training courses and webinars, there are also recordings you can order and watch any time. Just take a look at the complete list of all recordings.

* also payable by credit card
American Express Visa Mastercard

icon
Additional dates on-site
Additional dates on-site
not available
icon
Additional dates online
Additional dates online
not available
icon
Recording
Not available

Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

Woman with headset

Go back

Testimonials about our courses and conferences

"Great material and speakers" and "Great speakers a lot of experience and sharing"

Felipe Gonzalez, Mucos Emulsionsgesellschaft mbH
Live Online Training - Granulation & Tableting, September 2024

"I am so grateful for having attended this course. Great job from all, and very profitable. Thanks!”

Alba Aranda Cuesta, Kern Pharma
KPIs and Quality Metrics, Berlin, Germany, April 2025

"The lectures were very informative, interesting and entertaining."

Albert Godoy Hernández, Company synaffix
Live Online Training - GMP Auditor Practice, October 2024

"Really useful training which I will use in my daily work."

Regina Mommaerts, Galapagos NV
Live Online Training - GMP Auditor Practice, October 2024

"Wonderful format of the sessions: Good range of participations and experience in the team. Would love to attend another one soon."

Roopasi Mathi, Wacker Biotech B.V.
Live Online Training - GMP Auditor Practice, October 2024

"Very good balance between general and detailed information"

Dr Ralf Albrecht, Tillotts Pharma AG
Live Online Training - Granulation & Tableting
September 2024

"Nice presentations: easy understanding, quite visual"

Susana Manrique, Boehringer Ingelheim España, S.A,
Live Online Training - Granulation & Tableting, September 2024

“Fantastic course – I really enjoyed the interactive structure & greatly appreciate social activity.”

Anthony Cummins, Sebela Pharmaceuticals, Ireland
GMP Auditor Practice, September 2023

 

“Very well organized, information on point without being overwhelming.”

Eleni Kallinikou, Pharmathen
Live Online Trainng - Pharmaceutical Contracts - Febuary 2024

 

“Good overview of different types of agreements, good to see both the GMP and the legal angle”

Ann Michiels, Johnson&Johnson
Live Online Trainng - Pharmaceutical Contracts, Febuary 2024

 

 

“Both, organizers and lecturers were very friendly, open for discussions and extremely constructive. The course was a valuable experience for me.”

Maria Dimitrova, NKN Law Firm
Pharmaceutical Contracts: GMP and Legal Compliance, March 2025