The Life Sciences industry is the engine that drives access to excellent health for all. To meet their very high quality control standards, it is essential to have a wide range of resources and a thorough understanding of their capabilities. Good Manufacturing Practices (GMP) cover all aspects of drug and medical device production, and their implementation is of enormous importance, particularly in controlled areas.
Product protection
Both the GMP and the Standard Operating Procedures (SOP) are aimed at preserving quality and offering the public products with the highest level of safety. To achieve this, it is essential to have strict environmental control, which involves the absence of particles, pyrogens and contamination, both in the raw material and in the finished product. It should be noted that, in the vast majority of cases, the requirements of the SOPs are much more specific and exceed those contained in the GMPs issued by the regulatory authorities.
In this regard, the functions of the quality control and validation areas are the most important. Every aspect of manufacturing must meet a high level of sanitation and hygiene, which affects equipment, facilities, containers and materials.
There is one point that is transcendental. These are the personnel in charge of each stage of the production process, who must be duly trained and have suitable PPE. The reason is that these elements not only protect the worker, but also the installations and the products. And in this sense, Ansell is the best alternative for protection at every stage of manufacturing.
Personal protective equipment in controlled areas
Thanks to our experience, which we have acquired over more than 100 years, we are able to offer a wide range of innovative products. As manufacturers, Ansell's team of 14,000 employees is able to provide the best guidance in selecting personal protective equipment for each particular requirement, especially for finished product protection , as we will see below.
Raw material warehouses
In these areas, protection is required for cleaning tasks on equipment, structures, plant facilities and vehicles. There are, therefore, mechanical, chemical and biological hazards.
We offer AlphaTec® gloves in models made of nitrile, neoprene and PVC. EDGE® 14-633 have a rough finish and are made of PVC. All provide the highest defense against the risks described above.
Product preparation
The requirements and risks are similar to those of the previous section. MICROFLEX® 93-260 neoprene and nitrile gloves provide superior protection against bases, acids and solvents. AlphaTec® 37-182 is a nitrile, long type, ideal for production areas. EDGE® 82-135 is textured, which gives it a firm grip and is also among those with the longest service life.
The AlphaTec® 2300 chemical protective suit, lightweight and resistant, provides an effective barrier against inorganic liquids. Comes with a hood for respirator use and a zipper cover flap.
Manufacturing area
In these controlled areas, the main tasks are the cleaning of buildings, equipment, structures and laboratories. Chemical and pathogen protection is required.
Nitrilite® 94-401 and 93-311 are made of nitrile, with a very low ion and particle content, making them ideal for preventing product contamination. AccuTech® 91-255 glove is a thick latex EPP, compatible with grade A/class 100 cleanrooms. The BioClean™ S-BDFC integrated boot suit is sterile and disposable, with non-slip soles. It is made of CleanTough material, which is lightweight, lint-free and antistatic.
Research, development and quality laboratory
The workers' duties are mainly focused on cleaning equipment and maintenance areas. The required protection is against mechanical and chemical hazards.
Our AlphaTec® 37-175 glove is made of nitrile and has cotton flocking, which reduces perspiration production. It is an effective and reusable protection, with remarkable resistance to abrasion and against a wide range of chemical hazards. Another glove of the same brand, model 58-735, is made of nitrile, with support and protection against a wide variety of chemical products and lacerations, thanks to INTERCEPT™ Technology. Its adjustment is optimized for high tactile sensitivity.
MICROFLEX® 93-260 is made of neoprene and nitrile, which provides an effective defense against aggressive chemical agents. It is a very soft material, with great fit, dust free and in the palm and fingers it reaches a thickness of 7.8 millimeters.
Controlled areas are the key to GMP. Without the precautions taken by the pharmaceutical industry on a daily basis, it would be impossible to offer safe and high quality products. Following us on our website is the best way to stay updated and well informed.