USP 797

 

! ATTENTION: Georgia Retail Pharmacies regarding USP 797 minimum floor space regulations.

The minimum floor space of a retail compound pharmacy shall be 150 square feet.
Authority O.C.G.A. Secs. 26-4-27, 26-4-28, 26-4-110. History. Original Rule entitled “Sufficient Space in Prescription Department” adopted. F. Oct. 6, 1970; eff. Oct. 26, 1970. Repealed: New Rule of same title adopted. F. Mar. 5, 2003; eff. Mar. 25, 2003.

– A compounding pharmacy must have all equipment required of a pharmacy in Chapter 480 – 10 of the Board Rules.

Turn-Key Solution #1

 

Ultrapure Technology, Inc. offers complete turn-key solutions for your USP 797 compliance needs: including modular cleanroom construction, pass thrus, HEPA filters, laminar flow benches, bio-safety cabinets, chairs, tables, modular laboratory casework and cleanroom cleaning and maintenance supplies.

Please see the following typical floor plan provided by a modular cleanroom:

You can download a pdf. of Turn-Key Solution #1 here: Turn-Key Solution #1

Features include: 6063-T5 Anodized Aluminum Structural Framing, 2″ Gasketed Cleanroom Ceiling System, Monolithic chemical resistant white polyethylene and clear polycarbonate wall panels, open swing doors, adjustable air relief grilles, integrated electrical raceways, with seam welded vinyl flooring with 4″ flash coving.

Turn-Key Solution #2

 

Installation instructions are provided or Ultrapure Technology, Inc. can provide installation requiring only 2 days! Additional cleanroom options are available including HVAC and renovations of existing space.

Another option includes a Negative Pressure cleanroom for Chemo Rooms!

You can download a pdf. of Turn-Key Solution #2 here: Turn-Key Solution #2


USP 797 Start Up Cleaning Kit

Remember, you will need to maintain your new cleanroom appropriately. Try our USP 797 cleaning kit!
Our kit includes any variation of the following:

 

  • 7-C30-99L-00 : Cleanroom Wipes, 9 x 9, 300/bg, 12 bags/cs.
  • 7-C1VS-99P-01 : Validated sterile cleanroom wipes, 9 x 9, 25/bg, 6 bags/pk, 10 packs/cs.
  • 6-LS7030-PC-24 : Pre-saturated wipes, 9 x 9, non-sterile, 70/30 IPA/DI, 30/resealable pouch, 27 pouches/cs.
  • 6-LS7030VS-PC : Pre-saturated wipes, 9 x 9, validated sterile, 70/30 IPA/DI, 30/resealable pouch, 27 pouches/cs.
  • 6-LS7030-685 : Pre-saturated wipes in a canister, 70/30 IPA/DI, 6 x 8.5, 100 wipes, one full canister with 11 foil pack refills/cs.

 

  • 6-LS7030-99BK-K50 : Pre-saturated wipes in a bucket, 9 x 9, 70/30 IPA/DI, 50/bucket, 4 buckets/cs. Non-sterile.
  • 6-2642 : Anodized aluminum “shorty” handle. 30″ telescoping handle, autoclavable.
  • 6-2651A : 7″ Frame for anodized handle.
  • 6-2643 : Anodized aluminum 92″ telescoping handle, autoclavable.
  • 6-2652A : 12″ Frame for 12″ mop head.
  • 6-VKMOP : 7″ wall mop head, 48 per case.
  • 6-MVKMOP : 12″ wall mop head, 32 per case.

You can download information on USP797 cleaning kits here: usp797_2007 , USP797 Kit Contents

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