Since it was founded seven years ago, Pharmaesthetics has followed one fundamental precept: to provide its customers with products that are not only of excellent quality, but also highly safe. For this very reason, both the plant and the protocols for the manufacture of hyaluronic acid injectables have been designed to achieve the highest standards in this regard.
From the team's grooming to the type of ventilation in the room, from gestures when handling components to hygiene rituals, everything is organized to minimize the risk of contamination to the extreme. Find out about the main steps taken by the company to deliver reliable products to the market.
Control starts with the air
The care begins in the environment dedicated to the manufacture of injectables. The production room is considered a clean area and today, according to parameters measured by external certification, it is classified as Grade C - in other words, with adequate control of existing microparticles.
To enter the room, team members pass through an anteroom. The pressure control between the room and the anteroom and between the anteroom and the outside environment creates two sweeps in sequence, taking out any particulate matter present on uniforms and personal protective equipment (PPE).
In the room, a specific air filtration system, called HEPA, drastically reduces the presence of viable particles (microorganisms) and non-viable particles (coming from metals, paper, sand, pollution or dead cells, for example). This same system also provides laminar air circulation - instead of being injected into the room in a rapid, continuous flow, the air circulates in a smooth, orderly movement. The advantage is to reduce turbulence and avoid agitating any microparticles that remain in the work area.
Total care in preparing the team
If everything in the manufacturing environment is monitored in detail, the same goes for the rituals performed by the team involved in producing the injectables.
There are two separate areas in the changing room. In the so-called dirty area, the employee takes off the clothes they came from home with and leaves them stored in a cupboard. They then move on to the clean area, where they sanitize and dress in a previously sanitized and sterilized uniform (the garment covers all parts of the body and resembles a scuba tank, but is not rigid, but made of fabric).
When entering the production room, team members are instructed to make delicate gestures both when moving around and when handling the materials used. When they are not handling the product, they should keep their hands up, avoiding unnecessary movement and touching (equipment, colleagues).
At the end of the shift, all the uniforms used by the team are sent for further cleaning and sterilization. And it's worth mentioning: during work, microbiological tests are carried out on the uniforms in use. These tests are routine (daily) and serve to monitor contamination.
Attention also paid to equipment
The material and machinery involved in the production of hyaluronic acid injectables is also the subject of much attention. All the equipment used goes through a specially dedicated preparation area, where the parts are cleaned and sterilized in an autoclave.
The booths in which the injectables are manufactured are thoroughly cleaned between the production of each batch of product. And during work shifts, the benches are sanitized continuously. Team members use sterile tissues and alcohol to keep everything in perfect order.
All these procedures are validated by an annual certification process. At the end of each year, the plant stops working for around a month, during which time a series of tests are carried out to assess whether everything is being done optimally. Work only resumes once this process has been completed and a new cycle of injectable production begins.
