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Veltek Associates, Inc.
15 Lee Boulevard  Malvern, PA 19355-1234
Tel: (610)644-8335 Fax: (610)644-8336 E-mail: [email protected] so-01 Rev 27 July 2011
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STERI-OIL® 200
Sterile Pharmaceutical Clean Room Formula
PRODUCT DESCRIPTION
STERI-OIL 200 Sterile Lubricant is another innovation from VAI to assure the use of a sterile mineral oil lubricant within the
aseptic manufacturing area. Machinery lubrication is essential for manufacture of a product. At the same time, the use of a
sterile USP grade mineral oil lubricant is equally important to assure environmental conditions. STERI-OIL 200’s heavy
consistency provides lubrication and prevents metal to metal contact, withstands high friction without displacement, and
reduces metal fatigue. STERI-OIL 200 reduces items from sticking, penetrates and lubricates mechanisms and can be used for
moisture displacement. Packaged in our 1 ounce unit dose squeeze bottles, STERI-OIL 200’s sterility and analytical makeup is
assured for each lot. This product is aseptically filtered, double bag packaged and then gamma irradiated. The product is
delivered each time with VAI’s lot specific Sterile Documentation Packaging. This innovation represents another significant
breakthrough for clean room operation.
Product
Description
SO-200-A1Z Penetrating Mineral Oil
USDA No.
Filtration
Filled In
Flash Pt
H2
0.2 um
Class 100
370oF
ORDERING INFORMATION
Order#
Description
Quan/cs.
SO-200-A1Z
STERI-OIL 200 1oz. Dropper Sterile
250
Available Technical Data Supplements (Upon Request)
LUBE-1001: Sterile Lubricant and Cleaner Guide
Veltek Associates, Inc.
15 Lee Boulevard  Malvern, PA 19355-1234
Tel: (610)644-8335 Fax: (610)644-8336 E-mail: [email protected] so-01 Rev 27 July 2011
O V E R V I E W
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®
STERI-OIL 200
Sterile Pharmaceutical Clean Room Formula
SPECIFICATIONS
CHEMICAL:
CAS #
RANGE
Aliphatic Hydrocarbon
(Mineral Oil)
8012-95-1
100%
General Product Packaging/Filling Specifications:
FILLING:
Product is filled in Class 100 conditions.
FILTRATION:
Filtration designated per product is accomplished and integrity of the
filter assured by prior and post bubble point testing
PRODUCT LOT NUMBER:
Product Fill Lot Number is placed on the container label.
IRRADIATION LOT NUMBER:
Irradiation Sterilization Lot Number appears on the exterior of the
case. Dosage is Min: 25.0 kGy Max: 50.0 kGy
PACKAGING:
Product is double bagged per can in 4 mil polyethylene bags and
placed into a linered case. The entire contents are irradiated.
STERILITY TESTING:
Once processing has been accomplished, the product undergoes 14 day
USP <71> Direct Transfer Method in TSB (Trypticase Soy Agar) and
Thioglycollate Media. (20 samples/lot)
EXPIRATION:
3 years (36 months)
Veltek Associates, Inc.
15 Lee Boulevard  Malvern, PA 19355-1234
Tel: (610)644-8335 Fax: (610)644-8336 E-mail: [email protected] so-01 Rev 27 July 2011
O V E R V I E W
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STERI-OIL 200
®
Sterile Pharmaceutical Clean Room Formula
PRODUCT LABELING
All Product Labeling is Available Upon Request.
Veltek Associates, Inc.
15 Lee Boulevard  Malvern, PA 19355-1234
Tel: (610)644-8335 Fax: (610)644-8336 E-mail: [email protected] so-01 Rev 27 July 2011
O V E R V I E W
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Veltek Associates, Inc.
15 Lee Boulevard  Malvern, PA 19355-1234
Tel: (610)644-8335 Fax: (610)644-8336 E-mail: [email protected] so-01 Rev 27 July 2011
O V E R V I E W
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STERI-OIL 200
®
Sterile Pharmaceutical Clean Room Formula
Lot Specific
Sterile Documentation
(received with each shipment)
Certificate of Analysis
Certificate of Sterility
Certificate of Irradiation
(Please contact VAI for a sample of this documentation)
Veltek Associates, Inc.
15 Lee Boulevard  Malvern, PA 19355-1234
Tel: (610)644-8335 Fax: (610)644-8336 E-mail: [email protected] so-01 Rev 27 July 2011