87819 - Cosmetics Ingredients Analysis and Quality Assurance

Course Unit Page

SDGs

This teaching activity contributes to the achievement of the Sustainable Development Goals of the UN 2030 Agenda.

Good health and well-being Quality education Clean water and sanitation Oceans

Academic Year 2019/2020

Learning outcomes

- After completing the course, the student: - knows and can apply the sample preparation techniques and instrumental analytical techniques suitable for analyzing the raw materials for cosmetic use, to carry out a chemical-physical characterization, determine the concentration of specific active ingredients, and identify and quantify impurities, allergens and inorganic and organic contaminants; - knows and can apply analytical separation methods for the size/shape/spectroscopic analysis and characterization of nanomaterials employed in the cosmetic industry; - knows the environmental impact of the main components of cosmetic products as well as analytical and bioanalytical methods for the determination of emerging environmental pollutants (microplastics, nanomaterials, cosmetic residues); - knows the methods of chemical analysis for the determination of substances and materials of cosmetic products to evaluate the implications related to their release into the environment; - has the knowledge and the fundamentals, both theoretical and practical, related to system quality, Quality Control, Certification and Accreditation according to the national and international standards (ISO 9001:2015, ISO/IEC 17025:2005), the requirements of Good Laboratory Practice (GLP Good Laboratory Practice GLP) and Good Manufacturing Practices, the Good Sustainability Practice (GSP) for the cosmetic industry.

Course contents

The course includes two sessions of laboratory practical exercises. Attendance to laboratory exercises is compulsory. To attend the laboratory, it is requested that students have completed the compulsory course on safety at work and they have sent by e-mail to jessica.fiori@unibo.it a copy of the certificate of passing the final exam. Each student is required to procure and wear the chemical lab coat.

The course is divided in 4 modules.

Cosmetic ingredients analysis.

 Introduction: overview of active ingredients, chemical characteristic and function.

Theoretical, practical aspects and application of analytical approaches useful for the quality control of the ingredients (raw materials) used in the cosmetic formulations and for evaluating the presence of impurities or allergens.

Separation techniques: liquid chromatography, gas chromatography, capillary electrophoresis, with different detection system.

Spectroscopic techniques: UV-Vis spectroscopy (Derivative UV, derivatization), fluorescence spectroscopy, atomic absorption and emission spectroscopy, mass spectrometry.

Practical experience: bibliographic research on methods suitable for the analysis of a specific ingredients, presentation of this research.

The module includes laboratory exercises:

- Identification of oxidation dyes in raw materials for hair dyes by TLC separation on silica gel;

- Determination of the peroxide index in oils and fats by volumetric titration;

- Quality control of sweet fennel essence through GC-FID;

- Assay on lemon essence by UV-Vis spectrophotometry;

- Determination of the identity of the parabens and their degree of purity by HPLC-UV.

Cosmetic ingredients analysis in the environment

Key concepts: environment, Earth system, planetary boundaries, sustainability, Agenda 2030, life cycle assessment, pollution, environmental risk assessment.

Cosmetic ingredients in the environment: sources, properties governing distribution (vapour pressure, water solubility, partition coefficient Kow/Koc, biodegradation), chemical transformation (oxidation, reduction, methylation, sulphonation, chlorination), typical concentrations in natural waters.

Chemical analysis: composition of environmental matrices, matrix effects, sample treatment, solid/liquid extraction, liquid/liquid extraction, salting out, solid phase extraction, single-drop microextraction, solid-phase microextraction.

Laboratory exercise:

- analysis of UV filters in seawater by HPLC-UV,

- interpretation of GC-MS data,

- analysis of microplastics.

Introduction to quality management

Practical experience: Discussion of the bibliographic research carried out and application of the scientific method to a case/real research. You must present this research in order to participate to the exam.

Presentation and purpose of the course: Purpose of Analytical Chemistry and Quality System

Test on Analytical Chemistry concepts.

Introduction to Quality System: Fundamentals of Analytical Chemistry, The chemical-analytical procedure and the basic instrumentation, Glossary of the terms of Analytical Chemistry

Calculation and significant figures: the calculation and the significant figures in relation to the uncertainty (instrumental)

Concentrations and solutions: main expressions of the concentration. Parts per million (ppm), parts per billion (ppb), preparation of solutions

Bibliographic Research in Analytical Chemistry, with practical exercises

Correlation and regression: least-squares method, correlation coefficient and regression

STANDARDS AND CERTIFIED MATERIALS: Calibration; Comparators, transducers, sensors and biosensors, Classification of standards and methods of analysis. Standard and reference material (certified or not). Control standards. Control charts

SCIENTIFIC METHOD: PLACEBO EFFECT AND ALTERNATIVE MEDICINE: Scientific Method, Placebo Effect, Alternative Medicine, Meta-research, Discussion of the application of the scientific method to a real case/research.

QUALITY AND QUALITY CONTROL SYSTEM: Quality System and Analytical Quality Control, Reliability, Commutability, Reliability, Validation, Classification of standards (for atomic, definitive, primary, working, secondary) and analysis methods (definitive, reference, to known error, to unknown error), Standard and reference material (certified and not), Control standards (control serums), Control charts, Good Laboratory Practice, Certification and Accreditation.

Presentations by companies and institutions:

COSMETICA ITALIA: European regulations (Regulation 1223/2009 and Regulation 655/2013) and voluntary standards (ISO 22716) on cosmetic products. Outline of extra-European legislation.

Quality management in the cosmetic industry

Introduction, the concept of quality and its evolution to the total quality management approach. The pillars of total quality management.

The International Organization for Standardization (ISO). ISO9001:2015: the main concepts (customer focus, process approach, Plan-do-check-act Deming's cycle); structure of the standard and overview of the 10 clauses. Connections between ISO9001:2015 and UNI EN ISO 22716 and between ISO9001:2015 and (EU) No 655/2013 (and related Technical document) on cosmetic claims. Working with a Standard Operating Procedure (SOP).

ISO 14001:2015: structure of the standard and overview of the 10 clauses. Cosmetics Europe's Good Sustainability Practice.

Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) 1907/2006 EU;

Classification, Labeling and Packaging (CLP) 1272/2008 EU Regulations and their applicability to cosmetic industries.

Readings/Bibliography

- Editors: Amparo Salvador, Alberto Chisvert. Analysis of Cosmetic Products, 1st Edition (2007) oppure 2nd Edition (2017) Elsevier Science

- Manahan, S., Manahan, S. (1999). Environmental Chemistry, Seventh Edition. Boca Raton: CRC Press. E-book, accessible on-line (restricted) : http://www.crcnetbase.com/isbn/978-1-56670-492-2

- ISO standards, downloadable from the https://login.ihserc.com/login/erc website through the University convention and from a location with official credentials (recognition is made for IP number).

- Hage and Carr: "Analytical Chemistry and Quantitative Analysis" 1st edition by Pearson College Div (2010)

- Harris: "Quantitative Chemical Analysis" 8th edition by W. H. Freeman and Company (2010)

- Holler, Skoog, Crouch: "Principle of Instrumental Analysis" 7th edition by Brooks/Cole Pub Co (2017).

Teaching methods

Lectures in which the topics of the course are presented and discussed, with practical examples, vision of videos and explanatory numerical exercises.

In-depth seminars.

Laboratory activities with practical exercises in small groups, preparation of a report, with discussion on the exam.

Assessment methods

The assessment of learning takes place through the final exam, which ascertains the acquisition of the expected knowledge and skills through an oral interview on the entire program. As the course is divided in modules, the exam can be split at separated times of verification, as preliminary tests. The evaluations obtained in the individual modules are integrated to obtain the final exam grade by means of a final weighted average and have an annual validity deadline.

To take the exam, registration is required through Almaesami, in compliance with the deadlines provided for. You are encouraged to unsubscribe if not interested in taking the exam. The cancellation must be done before closing the list.

The evaluation criteria is based on the demonstration by the student of knowing how to use and apply the knowledge, information and cultural tools provided by the course, with discussion of the laboratory report. The threshold of sufficiency of learning is represented in particular by the demonstration of critical understanding and the ability to discuss the topics of the course.

The teachers are available for further clarification and to check the pre-exam preparation level by appointment.

Teaching tools

Videoprojector, PC, Internet and You Tube connections.

Office hours

See the website of Mara Mirasoli

See the website of Jessica Fiori

See the website of Daniele Fabbri

See the website of Stefano Girotti