- COSMETICS & SKINCARE PRODUCTS TESTING
- MEDICAL DEVICE TESTING
- TOXICOLOGY AND BIOCOMPATIBILITY
1. COSMETICS & SKINCARE PRODUCTS TESTING
Cosmetic products in Malaysia are regulated under the Control of Drugs and Cosmetic Regulations 1984. In conformance with the harmonization of cosmetic regulations in the ASEAN region, starting 1 January 2008, instead of registration, the companies will now be required to only notify / declare their compliance to the ASEAN Cosmetic Directive to the NPCB. Article 8 d of the ASEAN Cosmetics Directive 1 requires “Assessment of the safety for human health of the finished product, its ingredients, its chemical structure and its level of exposure”. This safety assessment is to be performed by a qualified professional defined as the “Safety Assessor”.
All cosmetics and skincare companies, whether they manufacture, import, or distribute cosmetic products must address the critically important issue of assuring the safety of their products and protect the consumers. General toxicological profiles for ingredients must be addressed. Potential irritancy of ingredients or mixtures of ingredients in finished products should be identified.
As far as skin is concerned, the two main untoward reactions to be avoided are skin irritation and skin sensitisation. Potential sensitizing ingredients or mixtures of ingredients should undergo predictive testing. Human data from skin compatibility tests ethically performed on the skin of human volunteers, supporting data for claimed benefits of cosmetic products should be made available to justify the nature of its effect.
2. MEDICAL DEVICE TESTING
A medical device encompasses any product used in healthcare for diagnosis, investigation, prevention, monitoring, cure and treatment of a disease or condition. It includes any instrument, apparatus, appliance, material or other articles, whether used alone or in combination, including the software necessary for its proper application intended for use in human beings.
Biological evaluation of medical devices must be performed to determine the potential toxicity resulting from contact of the component materials of the device with the body. The device material should not, either directly or through the release of their material ingredients produce local or systemic effects; be carcinogenic; or produce reproductive and developmental effects.
Therefore, evaluation of any device intended for human use should provide data from systematic testing to ensure that the benefits provided by the final product will exceed any potential risks produced by the device materials. The US Food and Drug Administration (FDA) 1995, in ensuring the safety of medical devices has enacted guidance for biological evaluation of medical devices incorporating the ISO 10993 testing matrix comprising in vitro and in vivo evaluations.
3. TOXICOLOGY AND BIOCOMPATIBILITY
We have track records in
dermatological research for cosmetic, medical devices and pharmaceutical product testing.
- ASSESSMENT OF BIOCOMPATIBILITY
AND SAFETY OF INGREDIENTS &
PRODUCTS - TOXICOLOGICAL STUDIES
- SAFETY AND EFFICACY EVALUATION
OF PRODUCTS, eg. cosmetics - CLINICAL STUDIES
Our specialised services include safety and efficacy assessment and testing of products. We complement standardized protocols with specific protocols based on our competence and the client’s needs.
List of studies/tests
- HUMAN STUDIES
1.1 Skin Irritation through Open Patch Test
1.2 Skin Irritation through Patch Test
1.3 Human Skin Irritation Test
1.4 Repeat Open Application Test
1.5 Test For Hypoallergenicity
1.6 Modified 21 Days Cumulative Irritation Test
1.7 ‘Modified Draize-95’ Test
1.8 Repeat Insult Patch Test (RIPT)
1.9 Patch Test On Sensitized Individuals
1.10 Human Maximization Test
1.11 Extended Prospective Product Use Testing
1.12 Comedogenicity Test
1.13 Human Ocular Irritation
1.14 Assessment Of Skin Following Repeated Wash
1.15 Safety Assessment Of Baby Bath Using Use Test
1.16 Assessment Of Whitening Effect Following
Repeated Use Of Test Materials
1.17 Assessment Of Antiwrinkle Effect Following
Repeated Use Of Test Materials
1.18 Barrier Efficacy Studies
1.19 Assessment Of Skin Barrier Recovery
1.20 Efficacy Assessment Of Topical Skin Products
On Cracked Heel
1.21 Assessment Of Effect On Nail Cuticles Following
Repeated Use Of Test Materials On The Fingernails - ANIMAL IN VIVO STUDIES
2.1A Primary Skin Irritation (ISO 10993-10)
2.1B Primary Skin Irritation (FDA)
2.2A Dermal Sensitisation Assay (Buehler)
2.2B Dermal Sensitisation Assay (ISO 10993-10)
2.2C Dermal Sensitisation Assay (ASTM F720-81)
2.3 Intra Cutaneous Toxicity (USP Standard)
2.4 Ocular Irritation Test (ISO 10993-10)
2.5 Acute Oral Toxicity (OECD 401)
2.6 Sub-Chronic Toxicity (OECD 408)
2.7 Systemic Injection Test (USP Standard)
2.8 Acute Dermal Toxicity (OECD 402)
2.9 Pyrogen Test (USP Standard) - IN-VITRO STUDIES
3.1 CYTOTOXICITY TESTS
Agarose Overlay Assay, Direct Contact Assay,
MTT Test, MEM Elution Assay
3.2 GENOTOXICITY
Ames Salmonella Reverse Mutation Assay
Micronucleus Assay, Alkaline Comet Assay
Healthmedic Research
We have a team of competent experts to provide study and testing services for safety evaluation of industrial and consumer products including cosmetics and skincare, medical and dental devices, chemicals, herbal products, and biomaterials. We are also competent in the safety assessment of cosmetic products.
We apply national and international standard protocols based on the ISO 10993, MS, ASTM testing regimes. We also provide advisory services on the relevant tests and test methods. Contract research and testing also form part of our service to the industry.
Human studies and clinical testing, safety and efficacy evaluations are done at various academic institutions and at our testing center headoffice, located in Bandar Sri Permaisuri, Cheras.
Besides conducting biocompatibility evaluation, we also offer a range of screening tests for products which are at R & D or pre-release stage. A close contact between sponsors and our study directors and consultants is essential so that possible modifications to the development process can be executed.
CONSULTANTS/RESEARCHERS
Dr Saadiah Sulaiman
MBChB, RCSI, (Dublin) M.Med. (UKM)
Study Director,Consultant Dermatologist
Dr Jeffrey Abu Hassan
MBChB, RCSI, (Dublin) M.Med. (UKM)
Physician
Dr Sharifah Ismail
MD (Medical Degree), Universitas Islam
Sumatra Utara/UISU
Dr Nani Atikah Yahaya
MBBS,SMC (Karachi)