Ricca R9192000-20S Sterile Purified USP/EP Water, 20L Poly Bag in Box

Technical Takeaway: RICCA R9192000-20S is sterile-filtered USP purified water marketed as WFI Quality. The product is documented for research and manufacturing and is explicitly not intended for direct parenteral administration. Qualification must consider the applicable water specifications, current manufacturing lot, integrity of the package and dispensing system, and the user's process requirements.

1. Understanding USP Purified Water and WFI-Quality Designation

Water is a critical raw material in pharmaceutical manufacturing, biotechnology, medical device processing, and analytical laboratories. Its suitability depends on chemical, microbiological, and application-specific quality requirements.

USP purified water is associated with compendial requirements addressing water purity, including conductivity and total organic carbon. Additional testing may be necessary when water is used in processes with defined microbial or bacterial endotoxin requirements.

RICCA describes this product as Water, USP Purified, STERILE Filtered, WFI Quality. The manufacturer documents conductivity, TOC, sterility, and bacterial endotoxin specifications consistent with its stated quality designation.

Important Distinction: "WFI Quality" is a manufacturer product description. It does not mean the packaged water is labeled or authorized for direct injection into patients. RICCA expressly restricts this product to research and manufacturing uses.

EP Qualification: Although the SOSCleanroom product listing references USP/EP, the manufacturer documents reviewed explicitly support USP-based testing. Obtain the applicable European Pharmacopoeia compliance documentation before approving this item for an EP-specific requirement.

2. Verified Product Identification and Specifications

• Manufacturer: RICCA Chemical Company
• Manufacturer Product Number: R9192000
• Manufacturer Part Number: R9192000-20S
• Product Designation: USP Purified Water, Sterile Filtered, WFI Quality
• Chemical Name: Water
• Formula: H2O
• CAS Number: 7732-18-5
• Molecular Weight: Approximately 18.02 g/mol
• Appearance: Clear, colorless liquid
• Odor: Odorless
• SDS-Reported pH: Approximately 7
• Relative Density: 1.00
• Purification: Reverse osmosis
• Sterile Filtration: 0.22-micron filter
• Filling Process: Closed-system filling
• Documented Filling Environment: Certified ISO Class 7 cleanroom
• Containment Preparation: Gamma irradiation before filling
• Package Volume: 20 liters (20,000 mL)
• Container: Polyethylene bag in protective fiberboard cube
• Dispensing Feature: Included spigot
• Purchase Quantity: One (1) 20-liter bag-in-box
• Unopened Shelf Life: 12 months
• Recommended Storage: 15-30°C (59-86°F)
• Intended Use: Research and manufacturing
• GHS Classification: Not classified as hazardous
• DOT/IATA Classification: Not regulated

Specification Note: The physical and chemical properties are taken from RICCA's R9192000 Safety Data Sheet. Sterility and analytical water-quality specifications are supported by manufacturer product literature and historical lot testing documentation.

3. Manufacturing Process: Purification, Filtration and Filling

RICCA's documented production process for R9192000 includes reverse-osmosis purification followed by sterile filtration and controlled filling.

1. Water Purification: Reverse osmosis removes a substantial portion of dissolved impurities and other contaminants from the source-water stream.
2. Sterile Filtration: Water is passed through a 0.22-micron sterile filter as documented by the manufacturer.
3. Package Preparation: The containment packaging is sterilized by gamma irradiation prior to receiving the water.
4. Controlled Filling: The water is transferred into its containment packaging through a closed system in a certified ISO Class 7 cleanroom.
5. Quality Testing: Manufacturer documentation reports tests for conductivity, organic carbon, sterility, and bacterial endotoxin content.
6. Lot Identification: Packaged material is associated with manufacturer lot, packaging, and expiration records.

RICCA states that no antimicrobial agents or other substances are added to the water. The product should not be described as a preserved aqueous solution.

Process Qualification: Sterile filtration and gamma irradiation of the empty containment packaging are separate operations. The documentation reviewed does not establish that the filled 20-liter unit undergoes terminal gamma irradiation or another terminal sterilization process.

4. USP Water-Quality Testing and Acceptance Criteria

RICCA's published water-quality documentation identifies the following analytical and microbiological testing specifications:

• USP <645> Conductivity: Maximum 1.3 µS/cm at 25°C for documented bulk-water testing; packaged water is evaluated against applicable USP requirements.
• USP <643> Total Organic Carbon: Maximum 500 ppb for the reported water-quality specification.
• USP <71> Sterility: No growth.
• USP <85> Bacterial Endotoxins: Less than 0.25 EU/mL.

RICCA's historical Certificate of Analysis distinguishes bulk-water testing from testing performed on the packaged product. This distinction is particularly relevant to conductivity and TOC measurements.

The packaged-water conductivity test is documented using an in-line measurement without temperature compensation. The measured temperature is reported so the result can be evaluated under the applicable USP conductivity procedure.

Testing Interpretation: A manufacturer specification is an acceptance criterion, not the actual test result for a newly purchased container. Obtain the Certificate of Analysis for the received lot to confirm results and disposition.

5. Conductivity Testing - USP <645>

Conductivity is a measure of a water sample's ability to carry electrical current through dissolved ions. Pharmaceutical water conductivity testing provides a means of evaluating ionic contamination.

RICCA's historical CoA identifies a maximum bulk-water conductivity specification of 1.3 µS/cm at 25°C and separately reports packaged-water conductivity results and measurement temperature.

USP <645> includes defined measurement conditions and acceptance procedures. A conductivity reading taken at another temperature cannot automatically be compared with a 25°C specification without using the applicable compendial evaluation approach.

• Verify the test is performed using the current applicable USP method.
• Distinguish actual measurement temperature from reference-temperature data.
• Review whether the CoA result refers to bulk or packaged water.
• Use the current lot-specific acceptance information.
• Prevent contamination during water sampling and measurement.

Conductivity Control: Low-conductivity purified water is susceptible to changes caused by contact with equipment, atmospheric carbon dioxide, unsuitable sampling containers, and dissolved ionic contamination.

6. Total Organic Carbon - USP <643>

Total Organic Carbon (TOC) is used to evaluate organic contamination in pharmaceutical-grade water. The manufacturer documentation identifies a TOC specification of maximum 500 ppb.

Organic contamination can originate from water-system components, container surfaces, transfer equipment, or sample handling. TOC results can therefore be sensitive to how packaged water is accessed and sampled.

The historical RICCA Certificate of Analysis provides a specific sampling recommendation: before performing TOC testing, flush the dispensing spigot with at least 1 liter of sterile-filtered water.

This recommendation concerns TOC sample preparation. It should not be interpreted as a universal dispensing instruction for every manufacturing or laboratory application.

TOC Testing Control: When conducting analytical verification, follow the manufacturer's applicable sampling instructions and the laboratory's validated procedure, including any requirements for pre-flushing, receiving containers, sample handling, and analytical blanks.

7. Sterility and Microbiological Quality - USP <71>

RICCA's water testing includes sterility evaluation under USP <71>, with a published acceptance criterion of No Growth.

This testing supports the manufacturer's packaged sterile-filtered water designation. The documented process includes a sterilizing-grade filtration step and filling into pre-sterilized containment packaging under controlled conditions.

A sterility test result represents testing performed under defined conditions. It should not be interpreted as a guarantee that mishandled, punctured, opened, or contaminated packaging will remain sterile.

• Verify receipt of an intact, correctly identified container.
• Check that the actual manufacturing lot satisfies required testing.
• Protect the original closure and dispensing outlet.
• Establish appropriate aseptic transfer procedures.
• Use a documented in-use hold time where repeated dispensing occurs.
• Apply additional monitoring or process qualification required by the facility.

Sterility Assurance Limitation: The manufacturer documentation reviewed does not provide a numerical sterility assurance level (SAL) for the finished 20-liter package. Do not infer or advertise an SAL value without manufacturer evidence.

8. Bacterial Endotoxins - USP <85>

Bacterial endotoxins are components associated with certain Gram-negative bacteria. Endotoxin control may be critical in pharmaceutical and biotechnology processes even when water meets specified chemical purity requirements.

RICCA documents a bacterial endotoxin specification of less than 0.25 EU/mL, tested under USP <85>.

Sterility and endotoxin testing address different quality characteristics. Water can meet one requirement without automatically meeting the other. Both must be evaluated independently where required by the application.

Endotoxin Qualification: The manufacturer's 0.25 EU/mL limit does not automatically meet every process-specific endotoxin requirement. Verify any stricter limits, sampling requirements, and current lot data before approving the water for the intended operation.

9. The 20-Liter Bag-in-Box Packaging System

RICCA R9192000-20S uses a proprietary polyethylene inner bag within a heavy-duty fiberboard cube. The manufacturer identifies carrying handles and an included dispensing spigot.

The fiberboard cube helps support handling and transportation. The inner bag contains the water and can be removed from the outer cube where an approved procedure permits this configuration.

• Inner Package: Polyethylene containment bag.
• Outer Package: Protective fiberboard cube.
• Nominal Volume: 20 liters.
• Dispensing: Spigot supplied with the package.
• Handling: Cube design includes carrying handles.
• Storage Flexibility: Manufacturer literature describes removal of the inner bag from the cube when appropriate.
• Receiving: Inspect both inner containment and outer package condition.

The package configuration can reduce the number of individual containers needed for larger-volume workflows. However, the outer cube is not documented as sterile cleanroom-transfer packaging.

Cleanroom Transfer: Do not assume the fiberboard exterior or outer surfaces are suitable for direct entry into classified environments. Apply the facility's approved segregation, transfer, and packaging-removal procedures.

10. Aseptic Dispensing and In-Use Contamination Control

Maintaining the quality of packaged sterile water after opening requires appropriate control of the dispensing interface and surrounding environment.

Repeated dispensing can introduce opportunities for microbial, particulate, ionic, and organic contamination. A spigot is a dispensing feature, not proof of a validated sterile closed-transfer system.

1. Confirm integrity: Inspect the bag, closures, and spigot prior to initial use.
2. Follow approved setup: Install or access the dispensing spigot using the manufacturer's instructions and facility SOP.
3. Protect the outlet: Minimize touching, splashing, or environmental exposure of dispensing surfaces.
4. Use appropriate receiving vessels: Select qualified clean or sterile containers as required by the application.
5. Control transfer conditions: Apply aseptic handling procedures when sterility must be maintained.
6. Prevent back-contamination: Do not return dispensed water to the original package.
7. Document first use: Record opening or dispensing-system activation when required.
8. Define in-use limits: Follow validated hold times or facility-approved use restrictions.
9. Monitor where required: Apply microbiological or quality-control testing appropriate to the process.

Critical Limitation: The manufacturer's 12-month unopened shelf life is not a validated in-use period after the container has been opened or accessed. A separate facility qualification is needed for repeated aseptic dispensing.

11. Storage, Shelf Life and Package Integrity

RICCA's documentation specifies 15-30°C (59-86°F) as the recommended storage range and 12 months as the shelf life of an unopened R9192000-20S package.

The SDS directs users to protect the product from freezing and physical damage. Package integrity and appropriate handling are particularly important for maintaining the water's original microbiological quality.

• Temperature: Store at the recommended 15-30°C.
• Freezing: Protect the water and packaging from freezing.
• Physical Damage: Prevent punctures, compression damage, leaks, or package rupture.
• Closure Integrity: Maintain original seals prior to use.
• Contamination: Keep dispensing surfaces protected.
• Expiration: Follow the manufacturer-assigned expiration date for the received lot.
• In-Use Control: Apply the facility's qualified hold time after the container is opened.

Shelf-Life Qualification: A historical certificate confirms a 12-month unopened shelf-life specification for R9192000-20S. Verify the current lot label and manufacturer documentation rather than calculating a new expiration date from the purchase date.

12. Pharmaceutical, Biotechnology and Medical Device Applications

RICCA identifies this sterile-filtered water for research and manufacturing. Manufacturer literature describes suitability for equipment cleaning, rinsing sterile-product contact components, and chemical formulation processes where the water meets the applicable quality requirements.

• Pharmaceutical Manufacturing: Process-support water for qualified operations.
• Biotechnology: Research and manufacturing operations requiring documented water-quality attributes.
• Equipment Rinsing: Cleaning and rinsing components where the process specifies the applicable purified-water quality.
• Medical Device Manufacturing: Process and component cleaning applications subject to facility qualification.
• Analytical Laboratories: Research and method-specific water requirements.
• Chemical Formulation: Preparation of solutions where the water quality, microbial characteristics, and application requirements are compatible.

The product should not automatically be selected for injectable drug preparation, direct parenteral administration, or other clinical applications based solely on its WFI-quality description.

USP <1231> Consideration: The laboratory or manufacturer using packaged water remains responsible for determining whether it is fit for the intended clinical, analytical, or manufacturing process, particularly where the applicable method refers to a bulk water system.

13. Safety Data and Transportation Classification

RICCA's R9192000 Safety Data Sheet identifies the product as water and does not classify it as hazardous under the referenced GHS criteria.

• Composition: Water, CAS 7732-18-5
• GHS Hazard Classification: Not classified as hazardous
• GHS Signal Word: None required
• GHS Pictograms: None required
• DOT Transportation: Not regulated
• IATA Air Transportation: Not regulated
• Canadian TDG: Not regulated
• Ventilation: Normal room ventilation identified as adequate
• Eye Protection: Safety glasses or goggles under standard laboratory practices
• Storage: Protect from freezing and physical damage

The product's lack of chemical hazard classification does not eliminate microbiological contamination-control requirements or the physical handling hazards associated with a large liquid-filled package.

Safety Notice: Use the current manufacturer SDS, applicable facility safety procedures, and transport requirements. The reviewed SDS revision is dated February 28, 2023.

14. GMP Documentation, Receiving and Lot Qualification

Water used in regulated manufacturing may require documented verification of its identity, quality attributes, lot history, storage conditions, and process compatibility.

• Manufacturer Identification: Verify R9192000-20S and the 20-liter package configuration.
• Certificate of Analysis: Obtain the document corresponding to the received manufacturing lot.
• Conductivity: Confirm results and test conditions according to the applicable USP requirements.
• TOC: Confirm lot documentation and any sampling qualification requirements.
• Sterility: Review the applicable USP <71> test result.
• Bacterial Endotoxin: Confirm compliance with the process-specific acceptance limit.
• Packaging Integrity: Inspect the received unit and document damage or deviations.
• Expiration Control: Use actual manufacturer dating.
• Storage Records: Apply facility requirements for water storage and environmental conditions.
• In-Use Controls: Establish handling, monitoring, and hold-time procedures where applicable.
• Change Control: Qualify any substitutions or changes affecting water quality or use conditions.

Publicly available RICCA certificates for historical lots demonstrate the manufacturer's testing and reporting format. These certificates do not establish the analytical results for a current shipment.

Audit Point: Do not represent historical lot results, published limits, or manufacturer marketing descriptions as current batch-specific certifications. Approval should be supported by documentation for the actual material received.

15. Purified Water Selection and Product Differences

RICCA R9192000-20S: Sterile-filtered USP purified water, WFI Quality, in a 20-liter poly bag-in-box. Manufacturer documentation includes sterility and bacterial endotoxin testing.

Non-Sterile USP Purified Water: May be appropriate for processes requiring chemical purity but without a sterile-water requirement. Not automatically interchangeable with R9192000-20S.

USP/EP/JP Purified Water: A separately identified multi-compendial water designation. Verify the exact monograph compliance, package format, and microbiological requirements for the specific product.

Sterile Water for Injection: A distinct pharmaceutical article with its own compendial and labeling requirements. R9192000-20S is not intended for direct parenteral administration.

Facility-Generated WFI: Water produced and monitored through an appropriately qualified manufacturing water system. Its use requirements and operating controls differ from purchasing and dispensing packaged water.

Selection Principle: Select water by its actual documented monograph, chemical purity, microbiological requirements, endotoxin limit, packaging, method of use, and lot-specific certification. Product names alone are insufficient to establish interchangeability.

16. Frequently Asked Technical Questions

Is RICCA R9192000-20S sterile?

RICCA identifies the product as sterile-filtered water, and its documented testing includes USP <71> sterility with a no-growth acceptance requirement. Continued suitability depends on intact packaging and proper handling.

What is the sterile filtration pore size?

Manufacturer lot documentation identifies a 0.22-micron sterile filtration step.

Is the filled package terminally gamma sterilized?

The manufacturer documents gamma irradiation of the containment packaging before filling. This does not establish terminal gamma sterilization of the filled water package.

What is the bacterial endotoxin limit?

The documented RICCA specification is less than 0.25 EU/mL under USP <85>.

What conductivity specification applies?

The historical manufacturer CoA specifies a maximum bulk-water conductivity of 1.3 µS/cm at 25°C. Packaged water is evaluated according to the relevant USP <645> procedure with its actual measurement conditions.

What is the TOC specification?

The documented acceptance criterion is a maximum of 500 ppb total organic carbon.

Does the water contain preservatives?

RICCA states that no antimicrobial agents or other substances are added.

Does the water meet EP requirements?

The reviewed product-specific manufacturer records document USP compliance. EP compliance has not been independently verified for this SKU and should be confirmed with the manufacturer if required.

Can this water be injected into patients?

No. RICCA explicitly states that this product is not intended for direct parenteral administration.

What does WFI Quality mean?

It is RICCA's description of the quality characteristics of this sterile-filtered purified water. It should not be confused with authorization for injectable clinical use.

How much water is included?

One 20-liter polyethylene bag-in-box unit is supplied under part number R9192000-20S.

Does the package include a spigot?

Yes. RICCA's product literature identifies an included dispensing spigot for the 20-liter configuration.

Can the fiberboard cube enter a classified cleanroom?

The manufacturer's documented ISO Class 7 filling environment does not qualify the shipping cube for direct cleanroom entry. Follow the facility's material-transfer and contamination-control procedures.

How long is the unopened shelf life?

RICCA documents 12 months for unopened containers. Confirm the expiration date assigned to the actual received lot.

How long can water be used after opening?

No universal post-opening sterile hold time has been established in the reviewed documents. Follow the facility's qualified in-use limits and dispensing procedures.

Why does RICCA recommend flushing the spigot before TOC testing?

The historical CoA recommends flushing at least 1 liter before TOC sampling. This helps address sampling-interface effects when evaluating organic carbon in dispensed water.

Is a historical CoA valid for a new order?

No. Historical certificates demonstrate documented manufacturer testing but do not establish current lot results. Request the actual lot-specific CoA.

Is the product hazardous for transportation?

The referenced RICCA SDS identifies the product as not regulated under DOT, IATA, and Canadian TDG dangerous-goods requirements.

17. Manufacturer Documentation and Technical References

RICCA R9192000 Safety Data Sheet:
View Product-Family SDS (PDF)

RICCA Sterile Purified Water, WFI-Quality Product Literature:
View Manufacturer Product Literature (PDF)

RICCA Historical Certificate of Analysis, Lot 9208751:
View Historical CoA Example (PDF)

SOSCleanroom Product Listing:
RICCA R9192000-20S - 20 L Sterile Purified Water

Relevant USP References: USP <643> Total Organic Carbon, USP <645> Water Conductivity, USP <71> Sterility Tests, USP <85> Bacterial Endotoxins Test, and USP <1231> Water for Pharmaceutical Purposes.

Documentation Warning: Historical CoA lot 9208751 was packaged in August 2022 and expired in August 2023. It is provided only as an example of the manufacturer's analytical test reporting, not as a valid certificate for currently supplied material. Always obtain current lot-specific documentation when required.

Why Source Sterile Purified Water Through SOSCleanroom?

• Accurate Product Identification: Source the specified RICCA sterile-filtered water by complete manufacturer part number.
• Water-Quality Selection: Compare purified, sterile-filtered, and other water categories based on documented process requirements.
• Packaging Selection: Obtain the 20-liter bag-in-box configuration for larger-volume operations.
• Documentation Assistance: Request manufacturer safety information and available lot-specific quality records.
• Controlled Procurement: Source water alongside cleanroom consumables, laboratory reagents, and manufacturing-support supplies.
• Repeat Purchasing: Maintain consistent product identification and package configuration across approved supplier programs.

For sterile purified-water sourcing and manufacturer documentation assistance, contact Sales@SOSsupply.com or call 800-443-7101.

The Technical Vault By SOSCleanroom | Information reviewed October 13, 2026
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