We don't just execute projects, we build relations that last a lifetime.

DESIGN

Pharmaceutical HVAC is one of the most crucial utility for any type of facility, be it OSD, Injectable, Hormone, MDI, Cytotoxic, and so on. Moreover, the energy consumption by HVAC alone is around 65% of the total plant. So, it requires engineers with sound technical expertise and experience to not only deal with these facts but to help you guide through the current regulatory trends and demands, be it, USFDA, MHRA, WHO, PIC/S, TGA MHLW , the ISO standards, or the recent Pharma 4.0 initiative.

The regulatory requirements within the pharmaceutical industry are becoming increasingly stringent. The GMP regulations are subject to constant development, although clear instructions are rarely issued. And to make matter even worse every country has their own regulatory body with each regulatory having its own set of rules so harmonization of these regulatory bodies is a task. Nevertheless, your investment has to be fit for the future, so you can be rest assured that there will be no flaws on the regulatory front. This requires a careful analysis of the demands made by authorities and a reliable interpretation of the GMP regulations with a Risk Assessment to adhering to the compliance.

EXECUTION AND PROJECT MANAGEMENT

The pharmaceutical industry is undergoing rapid changes, competition will increase continuously, while pressure of costs on individual companies will continue to rise. This requires the development of more efficient solutions, with new paths being trod in the process. Current projects have to be executed within ever shorter time limits and are subject to strictly predetermined budgets. Meanwhile, The technology thereby employed has become increasingly complex and demanding.

The key to sound execution is coordination not only with the consultants but other contractors as well. An optimum flow of information between the disciplines is crucial to a project's success or failure. A team of specialists with interdisciplinary knowledge is required in order to work together to interlink these elements while ensuring safety, efficacy, and efficiency.

VALIDATION, QUALIFICATION, AND DOCUMENTATION

After installation and cleaning, the clean rooms  will be subject to extensive tests. Our qualification and validation team will provide and support you with the necessary information on complying with the room's conditions in terms of ventilation, differential pressure, temperature, humidity, particles and microorganisms, smoke studies, temperature mapping, where required, during qualification.

We put a lot of effort and focus on documentation as they are the nuts and bolts of the entire plant. The efficient coordination of acceptance tests, commissioning activities and qualification is our top priority. This integrated process helps us to avoid double work and allows us to qualify the facilities quickly and efficiently. If any discrepancies arise, these are documented and dealt with "change control system".

WITH CLEANING AND COMPUTER SYSTEM VALIDATION

• The early integration of all elements of the qualification process is the key to success. Important decisions are now made during the development of the validation master plan and the initial risk analyses, which may have a significant effect on project.

WITH DUCT LEAKAGE TESTING

• Once the ducts are installed the duct leakage test is done as per the SMACNA Standards with a duct leakage test machine and the reports along with individual ducting drawings and measurements are prepared as a form of record which is handed over to the client.

AND MOST IMPORTANTLY,

we provide all the required assistance and backups during your regulatory audits so that you don't have to worry on your big day. 

OPERATION AND MAINTENANCE - POST PRODUCTION SUPPORT

Nobody can maintain your facilities as good as those responsible for their design and construction in the first place. This is precisely why we have made maintenance and technical facility management one of our top

priorities over recent years. At Airmax, the emphasis is on rapid fault repairs and preventive maintenance.

It goes without saying that we remain on call 24-7, all year through, at your disposal to solve those tricky problems. And, in the process, we don't solely contribute to secure facility operations, but also ensure that your facilities are equipped with a longer life-span. Additionally, regular requalification safeguard and document the GMP compliant status of your quality critical systems.