On Wednesday, Oct. 26, Happi attended both the quality assurance and microbiology workshops. “The Preservation of Personal Care Products” was the theme of the microbiology session, while quality assurance focused on “Quality and Compliance as a Competitive Advantage.”
Dr. John Krowka, senior environmental scientist for the Personal Care Products Council, welcomed attendees to the microbiology workshop. The first presentation was “Preservation of Personal Care Products: A Microbiologist’s View,” from Deidre Mitchell, microbiology manager at Unilever Research and Development Facilities in Trumbull, CT.
“Preservatives are essential ingredients added to a product to prevent and/or minimize the growth of microorganisms. They are added to products to protect the quality and consumer safety for the intended shelf life of a product,” she said. “Ultimately, preservatives are essential to protect the quality of the product and safety of the consumer.”
Mitchell emphasized that despite adequate product preservation and the following of cGMP (current good manufacturing practice), it must be recognized that personal care products are not immune to microbiological exposure (i.e. bugs). She also noted that formulators should never “chip away” at preservative levels to achieve cost-savings. According to Mitchell, successful preservation of personal care products involves the knowledge of: formulation and ingredients, including pH, ability of the unpreserved base to support the growth and replication of microorganisms; regulations and public relations issues about the preservatives under consideration; target consumer and consumer use habits; manufacturing facility where the product will be made; and intended life cycle of the product, including distribution.
The next presentation, “Formulation with Preservatives in Personal Care Products” from Irwin Palefsky of Cosmetech, was an overview of the different types of preservatives used in today’s marketplace. A cosmetic industry veteran with more than 40 years of experience, he has served in various positions in R&D.
“The preservative system is not a replacement for good hygiene/cleanliness during manufacturing,” noted Palefsky. “Also, the preservative system is not intended to replace microbial control of raw materials or water used in the formulation.”
All preservatives must be in the water phase of the formulation, he added.
Palefsky then presented commonly used preservative ingredients, such as benzyl alcohol and chlorphenesin; as well as “natural” alternatives such as essential oil combinations (cinnamon leaf and lemongrass oils). He also shared some “non-traditional” preservative combinations, such as caprylyl glycol and ethylhexylglycerin; as well as a variety of successfully tested formulations.
“Work with a preservative supplier who will screen preservatives in the base formula,” suggested Palefsky.
Phil Geis of Geis Quality Consulting presented “Preservation of Atypical Products.” His presentation was all about the “atypical” in personal care. Through almost three decades with P&G microbiology, Geis managed preservative and disinfectant development and studies of household and skin microbial ecologies and hygienic manufacturing.
“An atypical product rarely fits into an existing risk manufacturing and consumer use assessment,” he explained. Factors such as materials, packaging, delivery or consumer usage can make a product “atypical.”
For example, a product is atypical by raw materials when it features organic ingredients, geographically remote sourcing or aseptic manufacturing/terminal sterilization in the manufacturing process. Atypical by formulation is demonstrated by unique emulsions (water in silicone oil), multiple phases (ribbons, beads) or being labeled “preservative free.”
“In preservation of the atypical, there is a greater complexity of preservation. Therefore, compromise in preservation must be balanced with greater control,” concluded Geis. “It’s not just limited to what you see on the shelf. The packaging and raw materials, as well as consumer use, makes an impact globally.”
A panel discussion and lively Q&A session wrapped up the morning portion of this workshop.
Halyna Breslawec, Ph.D., EVP, science, Personal Care Products Council, introduced the afternoon session for the microbiology workshop. Doug Cole of Rockline discussed the challenges of preserving wet wipes; while Neal Machtiger of Microbiological Solutions/Bio-Control presented pointers on packaging, preservation and protection.
A session on preservation efficacy testing from Scott Sutton of Microbiology Network wrapped up this seminar.
Quality Assurance Workshop
Breslawec of The Council also welcomed attendees to the quality assurance workshop. John Avellanet of Cerulean Associates presented “How to Influence Management on the Importance of GMPs.” A segment on audit readiness then followed from Khurshed Kutky of QMI-SAI Global.
After the break, Manuela Coroama of COLIPA, the European Cosmetic Association, offered a presentation, “GMPs in the EU and the Concept of Harmonized Standards;” then Karyn Campbell of the FDA offered an update on the administration.
In the afternoon, Harry Koharcheck, vice president of quality assurance, Aveda Corporation, delivered a presentation on quality metrics. His benchmark survey delved into everything from companies’ quality assurance budgets to annual percentage of microbiological rejects.
“Supply Chain Oversight” was then delivered by Peter Kitz of Rx-360. His presentation focused on pharmaceuticals and was fitting, as he is also the vice president for Latin America & Asia Pacific quality operations for Merck. But some of these tips may also prove fruitful for the personal care industry with the rising demand for cosmeceutical skin care products.
“Illicit activity is present and threatens the safety of medicines,” he said. “But momentum is building.” The industry is conducting more thorough audits, focusing on supply chain security and implementing company specific solutions.
However, “greater achievements are required because the threats are not slowing down,” added Kitz.
After a break, David Coker of Alfa Laval discussed cleaning and sanitation issues. Then, Bill Hall, Ph.D. of Hall and Associates presented “Cleaning Validation.”
According to Hall, companies and regulators spend a great deal of time “peeling back the onion” to find the source of the problem. But the problem could be almost anything—raw materials, manufacturing procedures, cleaning procedures, microbial, inadequate training or even criminal activity.
“Know thy processes and products,” he concluded.