Industries

Pharma and medical device

In a regulated plant the cleaning record is part of the batch record. We clean to your procedures, keep the lot numbers and contact times, and hand your quality team a log they can file without rewriting.

A pharmaceutical filling suite with a stainless filling line, glove-box isolators and two people in white coveralls beyond.

What changes in this building

The log is a quality record.

  1. Procedures

    We clean to your SOPs by number and revision; a change on your side changes the scope on ours.

  2. Lots and contact times

    Every product, lot and contact time in the record, by room.

  3. Deviations

    Reported the same shift, written up, corrected and signed.

  4. Production floors

    Lane markings, epoxy and packaging areas kept to spec on the floor-care schedule.

  5. Offices and warehouse

    Nightly janitorial around the plant, with the same crew lead.

A man in a navy shirt steers a floor scrubber far down a clean warehouse aisle between tall racks of white bins and boxes.
A stainless steel floor drain with a slotted grate set in a gray resin floor, water droplets around it.

Inside the room

The procedure reaches every surface.

Agree the room, the method and the record before any work begins. Cleaning supports your quality system; it never replaces it.

  1. Planned with the facility and quality teams; filter faces stay yours.

  2. The approved operating conditions decide when we may be in the room.

  3. Accessible returns in the written scope, on their own frequency.

  4. Approved products, documented steps, contact times kept.

  5. Entry training complete and recorded before access.

Services for this building

What a pharma scope usually contains.

Regulated rooms

  • A person in a white coverall, hood, goggles and mask wipes the side of a large stainless vessel with a white cloth.
  • A man in a white coverall, hairnet and gloves wipes the rail of a conveyor in a packaging hall, a colleague far behind.
  • A woman in a navy polo and blue gloves wipes a stainless counter in a gowning corridor, two people in white behind her.
  • A person in a white coverall, hood and mask wipes the inside wall of a stainless isolator through its glove ports.

Questions from quality teams

Can your crews be qualified under our training system?

Yes. Site training and gowning qualification are done on your system and your forms, and the records live where your other training records live.

How do you handle a chemistry change?

As a scope revision with a date, so the record shows which product was in use on which day.

Do you support audits and inspections?

Yes. Training records, lots and logs are produced as one package in the format agreed in the scope.

Request a site walk

Share your contact details so we can arrange a site walk and discuss the service your facility needs.

Call 650-599-0202