Chemicals and Solvents

The United States Pharmacopeia Convention (USP) lists stringent procedures for sterile drug preparations (CSPs) in Chapter 797. Regulations are put in place to ensure the safety of patients receiving compounded formulations. All pharmacies, including those in care settings such as hospitals, operating rooms, ambulatory, etc., are required to be compliant with 797 guidelines.

https://www.usp.org/compounding

 Compounded sterile preparations 

• Injections, infusions 
• Ophthalmic dosage forms 
• Pulmonary inhalation preparations 
• Baths/soaks for live organ tissues 
• Implants

Not required to be sterile 

• Irrigations for mouth, rectal & sinus cavities

Quick Guide for Keeping Your Pharmacy Controlled Environments Sterile

Ensuring that the cleanroom is sterile is crucial for safe drug delivery. CPSs are produced in ISO class 5 primary engineering control (PEC) cleanrooms that are supplied by HEPA-filtered air and supported by an anteroom. To ensure that best practices are followed, each staff member involved in sterile compounding must retrain and be reviewed every 12 months. 

Minimum frequency for cleaning, disinfecting, and applying sporicidal PEC areas
Site	Disinfecting	Cleaning	Apply sporicidal
(Product)	(70% Sterile IPA, no-residue disinfectant)	(Sterile water for injection, sterile water for irrigation, disinfectant)	(Sporicidal)
ISO Class 5 PEC and equipment	Beginning of each shift, before each batch, every 30 minutes unless compounding takes longer than 30 minutes, after spills, when surface contamination is known/suspected	Daily or when surface contamination suspected	Monthly
Counters and easily cleanable work surfaces	Daily	Daily - work surfaces           Monthly - underneath work tray	Monthly
Floors	Daily	Daily	Monthly
Pass-throughs	Daily	Daily	Daily
Walls	Monthly	Monthly	Monthly
Ceilings	Monthly	Monthly	Monthly
Storage, shelving	Monthly	Monthly	Monthly
Work surfaces and equipment outside the PEC	Monthly	Monthly	Monthly

https://www.sefh.es/fichadjuntos/USP797GC.pdf

Cleaning procedure for PEC: When cleaning, disinfecting, or applying sporicidal agent, clean in the order of cleanest to dirtiest and highest to lowest.

1. Remove debris with sterile water and low-lint wipers
2. Use a cleaning agent, then a disinfectant/sporicidal (make sure that recommended dwell time is achieved)
3. Apply 70% sterile IPA or a residue-free disinfecting agent and allow to dry

Items introduced to PEC:

1. Before any item is brought into the Secondary Engineering Control (SEC), it must be cleaned, disinfected, and treated with a sporicidal. 
2. Before it is brought into the PEC, 70% sterile alcohol must be applied and allowed to dry.

Surface disinfection sampling of ISO classified area: Conduct after initial garbing as well as every 6 months or when procedural/cleaning changes are implemented.

Hand hygiene: Gloves should be wiped/rubbed with 70% sterile IPA and allowed to dry thoroughly before compounding and whenever nonsterile surfaces (chairs, carts) are touched. Observe staff every six months

Garbing:

• Low-lint gown or coveralls that fit snugly around wrists
• Low-lint, disposable shoe covers
• Low-lint hair/beard cover(s)
• Face mask
• Sterile, powder-free gloves
• If using a restricted-access barrier system (RABS), non-sterile gloves should be worn underneath sterile gloves
• Observe staff every six months

Compounding:

• Disinfect injection ports with 70% sterile IPA swabs
• Sterilization-grade filter membranes are 0.22-0.2μm pore size.
• Each staff member is reviewed for media fill testing every six months

Products for Sterile Compounding

From sterile 70% IPA that is conveniently packaged in spray bottles, to cleanroom apparel, Lap Pro conveniently offers a variety of products for your PEC stockroom.

Lab Pro Products	Purpose	Lap Pro Product #	Link
Sterile Isopropyl Alcohol ( IPA ) 70% Spray Bottles - Pint	Disinfecting PECs	ZP1857-16	Sterile Isopropyl Alcohol ( IPA ) 70% Spray Bottles - Pint
Sterile Isopropyl Alcohol ( IPA ) 70% Spray Bottles - Quart	Disinfecting PECs	ZP1857-32	Sterile Isopropyl Alcohol ( IPA ) 70% Spray Bottles - Quart
IPA 70% STERILE 1Qt SPRAY (Exp)	Disinfecting PECs	ZP1857-32	IPA 70% STERILE 1Qt SPRAY (Exp)
IPA 70% STERILE 1Qt SPRAY Case	Disinfecting PECs	ZP1857	IPA 70% STERILE 1Qt SPRAY Case
Metricide Plus 30 DISINFECTANT	Disinfecting PECs	C2304-128	Metricide Plus 30 DISINFECTANT
Sporicidin STERL/DISFCT	Sporicidal for ISO Class 8 Anterooms	C2307-128	Sporicidin STERL/DISFCT
Sporicidin Test Kt for Sol.	Sporicidal test kit for surfaces	C2307-2	Sporicidin Test Kt for Sol.
Coventry 66000ST Sterile Flocked Sampling Swab (Bag of 500)	Disinfect injection ports	LP-66000ST	Coventry 66000ST Sterile Flocked Sampling Swab (Bag of 500)
RICCA Sterile Water Purified 20L USP (WFI Quality)	Cleaning	LP-R9192000-20S	RICCA Sterile Water Purified 20L USP (WFI Quality)
RICCA Sterile Water Purified 200L USP (WFI Quality)	Cleaning	LP-R9192000-55S	RICCA Sterile Water Purified 200L USP (WFI Quality)
Lab Pro Masks LP-MaskSurg-W	Facemask for PEC	LP-MaskSurg-W	Lab Pro Masks LP-MaskSurg-W
Cleanroom Apparel	Head caps, shoe covers, nonsterile gloves, tacky mats		Cleanroom Apparel
FILTER SYRINGE .22um 30mm PES Sterile		F3128-2	FILTER SYRINGE .22um 30mm PES Sterile
FILTER SYRINGE .22um 13mm PVDF Sterile		F3127-2	FILTER SYRINGE .22um 13mm PVDF Sterile

Note: These chemicals are meant to be used for research, industrial work, cleaning or disinfecting and should always be stored out of the reach of young children or infants. 

For over 40 years, Lab Pro has been committed to delivering the highest quality chemicals, reagents, and cleaning solutions to medical and biotechnical laboratories worldwide. Come visit the biggest Lab Supply showroom in California or contact us online or at 888-452-2776.