Cleaning Procedures
Please note: We can only clean NEW bottles. We are unable to wash or re-clean used bottles. All bottles quoted for cleaning procedures must be purchased through CP Lab Safety.
Bottle Sterilization and Cleaning Services: Overview
Many of the bottles offered by CP Lab Safety can be ordered pre-cleaned and sometimes certified in the processes outlined below. To order a glass container pre-cleaned, find the part # you want and call us at (888) 322-5722 or email via the button below for a quotation.
Please note that bottles with caps assembled with glue, as well as safety coated glass items, are not cleanable. All pre-cleaned containers are supplied with caps attached, so only certain cleanable caps can be chosen. We offer a wide variety of custom bottle and closure combinations.
Sterilization: E-Beam Radiation Processing*
Get your bottles cleaned at the only X-Ray and DEA approved E-Beam facility in the USA. Our cleaning facility is ISO 11137 and ISO 13485 certified, FDA registered, DEA registered as well as State of California Medical Device and Drug Manufacturing licensed and serve the medtech, biotech, pharmaceutical and other industries. Our facility boasts two state-of-the-art 10 MeV, 20 KW linear accelerators, using simultaneous beam processing that allows for high volume production, providing uniform dose to the product. This DualBeam™ configuration significantly increases efficiencies, expands product options, and serves as an effective back-up for the accelerators. The facility will provide the most 10 MeV sterilization capacity, the most comprehensive product options, and the highest uptime availability than any other facility in North America.
*Both Glass and Plastic can be sterilized. However, color change may occur in certain circumstances. Some glass will darken and some plastics can discolor after undergoing this process. If you would like to test your container for discoloration prior to ordering, please call us at (888) 322-5722 or email us.
Non-Sterile: Premium Cleaning Procedures
Level 1 Cleaned** - STOCKED BOTTLES ONLY - only available on pre-cleaned stocked items and not to customer-submitted product.
Level 1 containers are processed to meet or exceed requirements of EPA "Specifications and Guidance for Containment Free Sample Containers". Analysis is conducted by an independent Laboratory and a traceable, lot-numbered specific Certificate of Analysis (COA) is provided with each case of containers. As additional quality control, each case is marked with the lot number and sealed with custody tape. Check out our Environmental Express Level 1 cleaned glass jars.
Level 2 Cleaned** - Level 2 Containers are similar to above but non-certified. This cleaning level is available to containers submitted by customers, as long as they are brand new. This is the best value for those who do not need a certificate.
Also available are standard stock items that are Level 2 cleaned, such as amber vials.
Particulate Cleaning
Process details: Glass containers with non-shedding Polypropylene caps and PTFE liners are processed using high purity 18 Meg-ohm water filtered to sub-micron levels for the particulate cleaning process. No detergents are incorporated, only high purity water is used. This process water meets and exceeds the criteria specified by the USP for Purified Water.
Common Applications: Pharmaceutical, Biotech, and Semi- Conductor industries. Used anywhere clean-rooms or controlled environments are utilized. Individual processed containers available with single, or double twist tied clean-room bags.
Certification Available: Certificate of Process- Containers are processed only with C of P included in each case. Certificate of Analysis- Containers are processed and tested by a third-party lab with Particle count, with a C of A included in each case.
Particulate Cleaning Protocols:
Protocol “A” – Semi-Volatile Organics, Metals, Inorganics
- (2) Automated cleaning system using (Trace grade Nitric Acid, ASTM Type 1 water and dried)
- Parameters: Analytes that are commonly analyzed
- Semi-volatile organics- base neutrals acids (BNAs), TOC, O&G, DRO, TPH. Low level PAHs
- Organochlorine Pesticides and alpha & gamma Chlordane
- Polychlorinated Bi-phenols (PCBs)
- Metals and Mercury
- Inorganics (Fluoride, Cyanide, Sulfate, Sulfide, Chloride, Alkalinity, Phenolics)
- Common containers used:
- Clear and Amber Packers
- Boston rounds
- Jugs
- Wide mouth straight-sided soil jars
- Assortment of HDPE plastics
- LDPE plastics and cubitainers
Protocol “B” – Volatile Organic Compounds Plus TICs
- Automated cleaning systems using ASTM type I water and dried
- Parameters: Analytes that are commonly analyzed
- Purgeable volatile organics
- Halogenated volatile hydrocarbons
- Aromatic volatile hydrocarbons
- Common containers used:
- 20, 40 and 60 ml Septa vials
- 4 and 8 oz straight-sided jars with PTFE Septa
Protocol “C” – Inorganics
- Semi-automated cleaning system (Trace grade Hydrochloric acid ASTM Type 1 water and dried)
- Parameters: Analytes that are commonly analyzed
- Inorganics BODs
- Residues- TS, TSS, TDS, Ammonia, TKN, Nitrate, Nitrite, COD (glass only, TOC, O&G)
- Common containers used:
- Cubitainers
- HDPE Modern rounds
- Cylinders
- Packers
- Nalgene®
- Straight-sided soil jars
Depyrogenation
Parental drug products must be manufactured to strict sterility guidelines using well-documented and validated aseptic processes. To meet this need, we provide our customers with glass vials prepared using validated processes that ensure the removal of bacterial endotoxins to acceptable endotoxin limits (0.25/EU/ml).
- Each glass vial is subjected to high dry heat treatment and multiple within an ISO clean room environment for terminal sterilization.
- Comes with full documentation and certification to meet regulatory requirements.
- Receive ready-to-sterilize product
- Dry heat treatment or multiple WIF rinses
- Vacuum sealed for extended shelf life
- Capable of processing large and small volume containers
- Small to large volume processing and custom packing of glass primary packaging containers
Barcoding and Taring
Custom marking to help identify and track critical assets and inventory to improve your processes, performance and control. We produce bottle labels and customize primary packaging components with alpha/numeric, bar code, and graduations.
- Custom markings can be applied to plastic and glass containers, and closure components to support traceability, positive identification, and anti-counterfeiting of packaged content.
- Primary packaging components can be delivered with pressure sensitive, custom marking, ceramic and screen labeling to assure data elements remain adhered to the container.
- Durable enough to withstand severe environmental conditions.
Shop from our extensive sterile and pre-cleaned bottles and vials or contact us for custom cleaning options.