The 2022 revision of EU GMP Annex 1, “Manufacture of Sterile Medicinal Products” marked a significant regulatory evolution in the pharmaceutical manufacturing landscape.
Among the many stipulations, one area that has gained critical focus is the classification of cleanrooms and its implications for cleanroom furniture design, material selection, hygiene protocols, and validation practices.
In essence, the Annex 1 framework defines how cleanroom infrastructure must support sterility assurance, right down to the benches, trolleys, and chairs that populate these tightly controlled environments.
Cleanroom classification & hygienic furniture requirements
Controlling contamination through effective particle management to achieve and maintain a sterile environment is critical to any efficient operation, and ISO-14644 is the standard by which concentration of airborne particles is measured.
EU GMP Annex 1 aligns with ISO 14644-1 and defines cleanroom classifications measured at rest as Grades A, B, C, and D. These grades directly inform the necessary level of cleanliness and, consequently, the specifications for furniture to be used within those zones.
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