Clean Room Poly Tubing

Clean room tubing is manufactured in a certified class 100 clean room.  This stock clean polyethylene tubing is produced from barefoot resin that meets FDA standards, wound on plastic cores and double bagged for added protection. Clean room poly tubing is ideal for use in packaging sensitive electronic instruments and parts.

Clean room tubing is made from low density polyethylene tubing. It is manufactured in a clean room environment for customers in the aerospace, electronics, pharmaceutical, and medical industries whose requirements specify ultra-clean packaging. The clean room level specified for the manufacturing environment of these products meets Federal Standard 209B for Class 100 particulate control.

• Barefoot Resin is made up of a virgin resin base with no anti-block or slip additives.
• All stock poly tubing is available for immediate pick up or shipment.
• Excellent for packaging products of varying lengths
• All sizes supplied on 12" diameter rolls
• 6 roll minimum 2-3 week lead time

CLEAN ROOM CLASSIFICATION FACT SHEET

CLEAN AREA: Environmental control of particulate and microbial contamination, constructed and used in such a way as to reduce the introduction, generation, and retention of contaminants within the area.

CLEAN ROOM AIR FLOW: There are commonly three types of clean room air flow:

1. Random Flow

a.   Hepa filters located randomly throughout the room to provide clean air.

2. Laminar flow, horizontal

a.   Provides an even, continuous, unidirectional flow of air from one wall in the room.

b.   Common in electronic production facilities

3. Laminar flow, vertical

a.   Provides an even, continuous, unidirectional flow of air from the ceiling toward the floor (the air is usually returned through baseboard vents).

b.   A vertical flow of clean air can keep activities occurring on the horizontal plane within the room separate.

Class Limits of Clean Rooms

* Expressed in Particles Per Cubic Foot

Particle Size (μm)

E.G.

Class 100 conditions (Critical Areas)   

According to guidelines given by the FDA, critical areas (those in which sterilized dosage forms, containers and closures are exposed to the environment) require Class 100 conditions, when measured 12 inches from the work site, and upstream of air flow. Air must be laminar flow, high velocity at 600 air changes per hour at 90 feet per minute, ± 20%. Microbial quality of t he air must be less than 10 cfu (colony forming units) per cubic foot, with a positive pressure of 0.05 inches of water to adjacent less clear areas.

Class 100,000 (Controlled Areas)

FDA guidelines stipulate that controlled areas (those in which unsterilized products or components are handled) are required to meet class 100,000 conditions. These conditions include 20-40 air changes per hour, less than 25 cfu per cubic foot, and a room pressurization of 0.05 inches of water relative to adjacent areas.