Introducing Wrapsa Laboratory
Author: Abby Vorster
Published in Pharmaceutical & Cosmetic Review – February 2018
If you’re looking for a local laboratory with world class analytical equipment and competitive pricing, Wrapsa Laboratory, trading as Talo Lab Services, is open for business. The company offers testing services for pharmaceutical products, complementary medicines, health products and food supplements.
The regulations, promulgated in the Government Gazette on 15 November 2013, require all pharmacological classifications of complementary medicines to be registered in terms of Act 101 by November 2019.
‘One of the biggest problems encountered when preparing dossiers for submission to the Medicines Control Council for registration is the lack of validated methods required for the generation of stability data,’ says Jannie Nel, responsible pharmacist at Wrapsa. ‘Apart from the new requirements for complementary medicines, at least one batch per product of all registered medicines manufactured within a calendar year in a GMP compliant facility, must be placed on ongoing stability studies.’
Wrapsa Laboratory has identified a business opportunity to supply laboratory services to the pharmaceutical and health products industries.
‘While the laboratory has been registered as a separate company, it is imperative that we maintain the Wrapsa branding to avoid any unnecessary changes to dossiers,’ Nel explains.
Equipped for Africa’s needs
Through a self-funded upgrade to its existing laboratory facility, Wrapsa has invested several million rand into developing Talo Lab Services as a key player in the pharmaceutical and complementary medicines markets. The facility and its team of analytical experts are equipped to perform testing on raw materials, intermediates and final products where a validated method or a pharmacopeial monograph method is supplied.
‘The current status of the classification of the laboratory is compliant with the licensing requirements required by the Medicines Control Council (including PIC/S requirements) and the latest ISO 9001:2015 code of practice,’ Nel explains.
‘We successfully completed our ISO audit in November and will be receiving our certificate soon, making Wrapsa the first contractor in South Africa to secure its 9001:2015 accreditation.’
With stability testing being a primary focus of the laboratory, Wrapsa’s management took a strategic decision to upgrade the stability chambers to enable stability storage and testing for local and international conditions. In doing so, the lab will be able to assist customers in determining the recommended storage conditions for their products while establishing shelf life information. The upgrade provides for 25°C/60 percent relative humidity; 30°C/65 percent relative humidity, to cover class three requirements based on Africa’s climatic conditions; and 40°C/75 percent relative humidity.
While the lab is already fully equipped and open for business, Talo Lab Services predicts an influx of business and will be installing a selection of new analytical equipment in the coming months. ‘Budget has been approved for additional HPLCs, vessel dissolution baths and humidity chambers, which will be added to the laboratory by the end of April,’ says Nel. ‘Thereafter, we aim to secure SANAS accreditation for the laboratory, for calibration and certification. This is the highest laboratory certification in South Africa and it is recognised by ISO.’
A fully equipped laboratory
TALO SERVICES HAS the following analytical instruments:
- infra-red spectrometry
- high pressure liquid chromatography (HPLC) UV/PDA Detector
- gas chromatography/FID detector
- atomic absorption
- ultra violet spectrometry
- density meters
- pH meters
- Karl Fischer titrators
- refractometers
- viscometers
- dissolution baths
- disintegration meters
- hardness testers
- friability testing apparatus
- ovens to test product loss on drying/sulphated ash
- wet chemistry testing equipment.
