Cleanroom TESTING and Pharmaceutical Suite Services
Cleanrooms are built environments designed to meet iso 14644 that are often utilised for critical applications. Regular cleanroom testing can help to identify and address any issues with the cleanroom. The environment must be used in a way that minimises the introduction, generation and retention of particles and microbes inside the room, and in which other relevant parameters such as temperature, humidity and pressure are controlled.
Contamination is one of the biggest risks to people, products, and the cleanroom environment, so these spaces must be constantly monitored and precisely controlled, for instance to stop the spread of virulent bacteria and viruses in the healthcare industry.
A critical component is the High Efficiency Particulate Air (HEPA) filter used to trap particles 0.3 microns and larger. All air supplied to the cleanroom passes through a HEPA filter, and ULPA (Ultra Low Particulate Air) filters are used when stringent cleanliness requirements and required, such as within the semi-conductor industry.
APPLICATIONS
Cleanrooms are required across a wide range of industries, such as:
- Hospitals
- Labs
- Pharmaceuticals
- Research and development
- Military manufacture & maintenance
- Fibre optics
AES Environmental has a dedicated team that is capable of carrying out assessment and validation work within cleanrooms. Our cleanroom team is discrete, reliable and applies the latest reporting techniques to ensure that the user has access to all the information in a timely manner.
MAINTENANCE
Unplanned downtime caused by malfunctions and breakdowns can be costly, consuming a lot of time and resources. The likelihood of plant failure and production downtime will be decreased by performing preventative maintenance. Your cleanroom facility’s mechanical components are crucial, especially when it comes to preserving the highest possible levels of containment and air sanitization. Components include:
- Air Handling
- Heating and Cooling Systems
- Duct Work
- Control and monitoring maintenance
- Air Filters (bag filters, HEPA Filters and Carbon Filters)
COMPLIANCE
AES is an ILAC accredited NATA testing organisation that provides validation services to ensure that the cleanroom and operator can comply with relevant TGA, GMP, FDA and other regulatory requirements, either regional or corporate.
AES partners with NATA and BSI to ensure that its technicians and processes are current to industry standards and the latest state of the art equipment and methodology is employed to ensure that validation services are conducted accurately and promptly.
Our validation team is there to work with quality and compliance team. We spend the time with users on-site to ensure that they are aware of any areas of concern, we can offer guidance or provide corrective action and ensure that expected performance meets actual performance.
PHARMACY SUITES
The use of cytotoxic drugs creates a need for a different set of solutions with their preparation, manipulation and compounding. According to AS 2252.5, many cytotoxic drugs have been demonstrated to be mutagens, some have shown to be carcinogenic or teratogens in cell DNA and chromosomal studies and the effects may not present themselves for many years after exposure. It is therefore essential to ensure that:
- There is effective protection of personnel
- Protection of the immediate surrounding environment and discharge
- Protection of the products, to ensure that they are manipulated within a clean and controlled environment
There are a special set of standards and procedures for ensuring that pharmacies are safe. Any Cytotoxic Drug Safety Cabinets should comply with AS 2252.5 and the rooms must meet a strict criteria in accordance with AS 1668.2. AES Environmental technicians are specially trained to identify hazards and operate safely within Cytotoxic Suites. The TGA has adopted PE009 PIC/S for GMP, AES Environmental has the knowledge and experience to assist with Pharmacy design, maintenance and review. Our experience with major global pharmaceutical companies and dedication to working within all compliance and regulatory requirements is essential in providing a safe, compliant work space.
STANDARDS
There is a particular application area for each clean room classification standard. The standard ISO 14644 has been adopted into Australian standards as AS/NZS 14644 2017 which is an international standard that aims to achieve the international standardisation of manufacture.
Your company should also look into relevant therapeutic goods or equivalent regulatory standards to determine any additional requirements. AES can assist with this investigation as a consultancy service.
Our Services
AES Environmental is able to provide packages for both routine and urgent cleanroom maintenance. We offer an extensive and thorough maintenance and repair service for all elements of your cleanroom, including the ventilation system, fixtures, and building materials like floors, ceilings and furniture.
VALIDATION DESIGN
Cleanrooms are now validated in two starts, in-use and at-rest. In-use testing was developed because at-rest testing may not generate a real-world result. There are many factors to consider as no two cleanrooms are ever the same and its because of this that our experienced team is able to sit with you and design a testing program, designate the optimal sample locations and then work within the on-site requirements to deliver that program.
VALIDATION EQUIPMENT
Each site many have specific methods that need to be considered. However, the most common instruments applied by technicians are photometers, particle counters, aerosol generators, pressure monitoring equipment and temperature monitoring equipment. All of the equipment that is used by AES technicians its itself validated it current standards and test reports are always made available to the user.
VALIDATION METHODS
Validation methods are typical within the cleanroom industry and there is good standardisation. Room recovery rates and particles counting for room classification along with leak testing of heap filters, air flow, pressure and temperature monitoring are critical components of cleanroom validation. Comfort tests related to sound and light are also of significance as optimal operating conditions are critical to reduction of employer error.
COMPLETE COMPLIANCE
AES environmental brings together the idea of designing as testing program, Ensuring all equipment is compliant and current and then adopting the latest validation methods, to deliver on its goal of making compliance simple and accessible for its customers.