Cleaning & Extraction Equipment for Pharmaceutical & Cleanroom Environments | V-TUF

Cleaning & Extraction Equipment for Pharmaceutical & Cleanroom Environments

Pharmaceutical manufacturing, medical device production and controlled environment facilities operate under MHRA Good Manufacturing Practice (GMP), EU GMP Annex 1 and ISO 14644-1 cleanroom classification standards. Cleaning equipment used in these environments must be validated, HEPA-filtered and constructed from materials that can be effectively sanitised and do not contribute particulate contamination.

The standards that apply

EU GMP Annex 1 (2022 revision) — the revised Annex 1 places significantly greater emphasis on contamination control strategy (CCS). Cleaning equipment specification is explicitly within scope of the CCS and must be documented, validated and maintained.

ISO 14644-1:2015 — cleanroom classification by airborne particulate. Grade A/B environments (ISO Class 5) through Grade D (ISO Class 8) each require different extraction and cleaning specifications. H-Class HEPA extraction is the minimum for Grade A/B cleaning operations.

MHRA GMP — UK regulatory framework for pharmaceutical manufacturing post-Brexit. Equipment must be fit for purpose, cleanable and not a source of contamination.

Equipment specification by cleanroom grade

Grade D / ISO Class 8 — general pharmaceutical production areas

H-Class HEPA extraction (H14, 99.995% at 0.3 micron) for all vacuuming operations. No standard industrial vacuum — exhaust recirculation introduces uncontrolled particulate into the classified environment.

V-TUF MIDI HSV — 21L H-Class, 110V and 240V

Compact sealed H-Class extraction. Suitable for Grade D general cleaning, equipment cleaning and spill recovery in pharmaceutical production environments.

View MIDI HSV →

V-TUF MAXi — 50L and 80L H-Class

High-capacity H-Class for deep-clean cycles and large production area cleaning in Grade C and Grade D pharmaceutical environments.

View MAXi → H-Class specification →

Potent compound handling — OEB 3 and above

Highly potent active pharmaceutical ingredients (HPAPIs) and occupational exposure band (OEB) 3+ compounds require H-Class extraction as a minimum containment measure during cleaning operations. Operator exposure limits for HPAPIs are typically in the nanogram per cubic metre range — standard vacuums provide no protection at these concentrations.

Contact the V-TUF technical team to discuss extraction specifications for HPAPI cleaning operations: 01522 787978

Cleanroom fit-out and construction cleaning

Pre-commissioning cleaning of new and refurbished cleanroom facilities requires H-Class extraction to remove construction dust before ISO 14644-1 particle count validation. CDM 2015 applies to cleanroom construction works.

CDM 2015 → Construction sector hub →

Floor scrubber dryers — production and corridor areas

Validated floor cleaning with documented water recovery — reduces slip risk and removes liquid from production floor surfaces. Stainless steel or sanitisable construction required for Grade C and D environments.

View tufSCRUB range →

Validation and documentation considerations

Equipment must be included in the site validation master plan (VMP) where it contacts product contact surfaces or is used in classified environments
Cleaning validation records (equipment cleaning logs, filter change records) form part of the batch manufacturing record audit trail
Filter integrity testing on H-Class units should be documented at defined intervals per the equipment qualification protocol
V-TUF can provide technical data sheets, filter specifications and CE documentation to support equipment qualification activities

Legislation and standards

COSHH Regulations 2002 — pharmaceutical dusts, APIs and cleaning agents are COSHH-controlled substances. Extraction equipment is the primary engineering control.

HSE EH40 — occupational exposure limits for pharmaceutical dusts and process chemicals.

H-Class dust extraction — full specification →

Pharmaceutical and life sciences trade accounts

V-TUF operates trade account terms for pharmaceutical manufacturers, contract development and manufacturing organisations (CDMOs), medical device manufacturers and specialist cleaning contractors serving the life sciences sector. UK stock, next-day delivery, technical documentation support.

Telephone: 01522 787978 | Email: enquiries@v-tuf.com