What is Annex 1?
GMPAnnex 1is the EU standard for “The Manufacture of Sterile Medicinal Products”. The manufacture of sterile products is subject to special requirements in order to minimize risks of microbiological, particulate and pyrogen contamination. For this reason, this new standard provides general guidance that should be used in the design and control of facilities, equipment, systems and procedures used for the manufacture of all sterile products applying the principles of Quality Risk Management (QRM), to ensure that contaminations are prevented in the final product. Annex 1principles include contamination control strategy, design of premises, cleanroom classification, qualification, validation, monitoring and personnel gowning. Some of the most relevant guidelines are set out below. “In cleanrooms and critical zones, all exposed surfaces should be smooth, impervious and unbroken in order to minimize the shedding or accumulation of particles or micro-organisms.” “Ceilings should be designed and sealed to prevent contamination from the space above them.” “Cleanrooms should be supplied with a filtered air supply that maintains a positive pressure and/or an airflow relative to the background environment of a lower grade under all operational conditions and should flush the area effectively.”
Stainless steel in clean environments
Stainless steel furniture and equipment can be found in most types of cleanroom environments, and that’s because of its unique features: stainless steel is durable, attractive, easy to clean, corrosion resistant, and able to withstand vigorous cleanings. In addition, stainless steel is theoretically 100% recyclable and its long-term life makes it an ideal environmental performer compared to other materials. There are more than 50 types of stainless steel grades recognized by the American Iron and Steel Institute(AISI), however the three most common types used in furniture and equipment in cleanrooms, labs, manufacturing facilities and sterile environments are grades 304, 316 and 430.
What is HPL?
High Pressure Laminate (HPL) is a composite material consisting of printed decoration paper fused to multiple sheets of Kraft paper saturated with a synthetic thermosetting resin.Heat and high pressure are used in a special thermosetting process to create flexible, high-density laminate sheets. The countertop surface patterns on the laminates are saturated with melamine and phenolic-based resins to provide higher resistance to abrasion, thermal and impact shock, heat and discoloration.HPL is a standard finish in controlled contamination environments which require low static generation, frequent access or ease of maintenance.It’s easy to clean, making it ideal for places and applications where high levels of hygiene are essential, such as laboratories, hospitals and clinics.