ADVERSE REACTIONS SECTION.

6 ADVERSE REACTIONS. Citrate reactions or toxicity may occur with the infusion of blood products to patients. The recipient of the blood containing citrate should be monitored for the signs and symptoms of citrate toxicity. The signs and symptoms of citrate toxicity begin with paresthesia, tingling sensation around the mouth or in the extremities, followed by severe reactions that are characterized by hypotension and possible cardiac arrhythmia. Citrate toxicity may occur more frequently in patients who are hypothermic, have impaired liver or renal function, or have low calcium levels because of an underlying disease.. Citrate reactions or toxicity may occur with the infusion of blood containing citrate. The recipient of the blood containing citrate should be monitored for the signs and symptoms of citrate toxicity. (6)To report SUSPECTED ADVERSE REACTIONS, contact Terumo BCT, Inc. at 1-877-339-4228 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

CLINICAL PHARMACOLOGY SECTION.

12 CLINICAL PHARMACOLOGY. 12.1 Mechanism of Action. ADDITIVE SOLUTION FORMULA acts to preserve and extend the shelf life of packed RBC products for later transfusion to patients. The following ingredients are key components of the solution:Adenine to support adenosine triphosphate (ATP) levelsCitrate for membrane protection, anticoagulation and pH regulationSodium (Sodium Chloride and Sodium Citrate) and dextrose for isotonicityDextrose for RBC nutritionThis solution has no pharmacological effect.. Adenine to support adenosine triphosphate (ATP) levels. Citrate for membrane protection, anticoagulation and pH regulation. Sodium (Sodium Chloride and Sodium Citrate) and dextrose for isotonicity. Dextrose for RBC nutrition.

CLINICAL STUDIES SECTION.

14 CLINICAL STUDIES. The in vivo and in vitro quality of RBCs stored for 42 days in ADDITIVE SOLUTION FORMULA (AS-3) storage solution has been assessed in three clinical studies.. In Vivo Recovery of Autologous Radiolabeled RBC single-arm, multicenter, in vivo study was conducted to assess the recovery of radiolabeled RBCs 24 hours post infusion. Acceptability of in vivo recovery was determined using established FDA-CBER acceptance criteria. Double collection RBCs (dRBC) were collected using the Trima Accel system and stored in ADDITIVE SOLUTION FORMULA (AS-3) solution for 42 days, then radiolabeled with 51Chromium, and transfused back to the original subject. Table summarizes the in vivo recovery data. Of the 27 units transfused, 26 had 75% RBC recovery.Table 2: In vivo Radiolabeled RBC RecoveryOutcome MeasureStudy Site (N)Average (SD)Min, MaxAbbreviations: Max= Maximum, Min= Minimum, N= Number of Units Transfused, RBC= Red Blood Cell, SD= Standard DeviationOverall Day 42 infused, 24-hour RBC Radiolabel Recovery (%)Site (12)79.3 (5.6)67.5, 86.5Site (15)87.1 (5.5)79.0, 98.1FDA-CBER Criteria for Acceptable Recovery: Radiolabeled RBC recoveries should average at least 75%, with standard deviation of at most 9%. In addition, the 95% one-sided lower confidence limit for the population proportion of successes should be 70%, with success being defined as an individual red blood cell in vivo recovery of at least 75%. No more than out of 24 data points may have less than 75% radiolabeled red cell recovery at 24 hours post infusion.The primary outcome was met for RBCs collected on the Trima Accel system and stored in ADDITIVE SOLUTION FORMULA (AS-3) storage solution.. In Vitro RBC Quality StudiesThe in vitro quality of RBCs collected in single RBC collection (sRBC) and dRBC procedures using the Trima Accel system was assessed after 42 days of storage in ADDITIVE SOLUTION FORMULA (AS-3) solution in multicenter, paired study. In vitro quality was determined using established FDA-CBER acceptance criteria. The quality of RBCs stored in ADDITIVE SOLUTION FORMULA (AS-3) solution (test) was compared to RBCs stored in plasma (control). Table summarizes the in vitro RBC quality data for collection on the Trima Accel system and storage in ADDITIVE SOLUTION FORMULA (AS-3) solution.Table 3: In Vitro Quality Measures for RBCs Collected using the Trima Accel System and Stored in ADDITIVE SOLUTION FORMULA (AS-3)Outcome MeasureSite (N)Average (SD)Min, MaxAbbreviations: HCT hematocrit, HgB hemoglobin, Max Maximum, Min Minimum, = Number of Units, RBC Red Blood Cell, SD Standard DeviationDay 42 Hemolysis for Single RBC CollectionPercent hemolysis was calculated from plasma free hemoglobin using the equation:%Hemolysis (100 RBC Product HCT) Plasma Hgb (RBC Product Hgb). (%)Site (32)0.16 (0.06)0.06, 0.33Site (18)0.34 (0.18)0.12, 0.70Site (18)0.26 (0.11)0.09, 0.47Day 42 Hemolysis for Double RBC Collection (%)Site (25)0.15 (0.05)0.06, 0.29Site (24)0.39 (0.19)0.16, 0.95Site (21)0.26 (0.12)0.13, 0.61Change in pH from Day to Day 42 for Single RBC CollectionThe difference in pH between Test and Control on Day 42 was calculated as:pH pHTest pHControl <= 0.5 where the difference was expected to be less than or equal to 0.5 pH units. Site (31)0.03 (0.02)0.00, 0.08Site (18)0.03 (0.03)0.00, 0.11Site (16)0.02 (0.02)0.00, 0.07Change in pH from Day to Day 42 for Double RBC Collection Site (23)0.02 (0.02)0.00, 0.05Site (23)0.02 (0.03)0.00, 0.15Site (19)0.02 (0.02)0.00, 0.08Ratio of ATP Retention for Single Collection RBC Units (test/control)ATP retention was determined for test and control units across all sites and calculated as ATP Level on Day 42 ATP Level on Day 0. All sites (65)1.02 (0.18)0.46, 1.47Ratio of ATP Retention for Double Collection RBC Units (test/control) All sites (65)1.07 (0.19)0.55, 1.51Ratio of the Normalized Leaked Potassium for Single Collection RBC Units (test/control)Normalized potassium was calculated by determining the total number of millimoles of potassium leaked from the RBCs into the supernatant volume and dividing this by the total hemoglobin in the stored product.Normalized Leaked Potassium Volume(1-Hct/100)(d42[K+] d0[K+]) Total Hemoglobin All sites (65)0.98 (0.07)0.76, 1.13Ratio of the Normalized Leaked Potassium for Double Collection RBC Units (test/control) All Sites (64)1.00 (0.08)0.85, 1.24FDA-CBER Criteria for Acceptable Day 42 Hemolysis: Zero failures (hemolysis >= 1% after 42-day storage) out of 60 test units that were not excluded from analysis by the Extreme Studentized Deviate test with =0.05, which satisfies the binomial distribution testing requirement that, with 95% probability and one-sided 95% lower confidence limit, the post-storage hemolysis was less than 1% per unit.There were 0/68 sRBC test units and 0/70 dRBC test units with Day 42 hemolysis >= 1%. No donors were excluded as hemolysis was 1% for all test units. Therefore, the primary objective was met for RBCs stored in ADDITIVE SOLUTION FORMULA (AS-3).The in vitro quality of sRBC and dRBC units collected using the Trima Accel system was assessed after 42 days of storage in AS-3 solution in multicenter study. The quality of RBCs was compared between sRBC and dRBC units, and between units and of the dRBC collection. Table summarizes the in vitro RBC quality data for collection using the Trima Accel system and storage in ADDITIVE SOLUTION FORMULA (AS-3).Table 4: In Vitro Quality Measures for RBCs Collected using the Trima Accel System and Stored in ADDITIVE SOLUTION FORMULA (AS-3)Outcome MeasureAll outcome measures are shown after 42 days of storage in AS-3 solution. SiteRBC UnitP ValueAll comparisons were performed using Students T-test. 2-tailed paired comparison was performed for dRBC v dRBC B. 2-tailed, two sample, equal variance comparison was performed for sRBC dRBC units. dRBC AdRBC BsRBCdRBC v dRBC BsRBC dRBCAbbreviations: dRBC = Unit of the Double Red Blood Cell Collection, dRBC = Unit of the Double Red Blood Cell Collection, sRBC Single Red Blood Cell Unit, SD Standard DeviationHematocrit (%), mean (SD)Site 154.4 (3.7)53.9 (3.6)55.8 (4.4)0.1320.253Site 256.0 (3.9)53.3 (11.6)58.4 (3.6)0.3980.149pH, mean (SD)Site 16.4 (0.04)6.4 (0.05)6.5 (0.08)0.7600.643Site 26.4 (0.1)6.4 (0.1)6.4 (0.1)0.1750.217pCO2, mean (SD)Site 1140 (8)137 (8)139 (12)0.1720.525Site 2130.5 (11.7)130.4 (12.4)125.6 (11.1)1.000.316pO2, mean (SD)Site 146 (7)47 (7)46 (7)0.1040.825Site 252.0 (10.6)51.4 (12.5)46.2 (3.4)0.8780.157ATP (umols/g HB), mean (SD)Site 12.6 (0.6)2.6 (0.6)2.9 (0.5)0.7590.306Site 23.0 (0.5)3.0 (0.6)2.6 (0.5)0.8450.110K (mEq/L), mean (SD)Site 146.5 (7.9)47.5 (8.2)49.3 (10.1)0.3960.620Site 240.5 (5.8)41.1 (5.9)44.7 (5.7)0.5750.128Na (mEq/L), mean (SD)Site 1122 (7)123 (6)126 (17)0.0160.609Site 2105.6 (5.4)104.2 (5.5)100.0 (5.5)0.0040.069Total Hemoglobin (g/dL)Site 160.5 (5.8)60.0 (5.3)61.0 (4.7)0.5460.627Site 258.5 (5.5)59.6 (5.8)60.3 (5.0)0.2640.747Plasma Hemoglobin (mg/dL), mean (SD)Site 1149.9 (151.6)141.2 (145.3)152.7 (86.3)0.0340.815Site 2139.0 (61.0)126.7 (80.4)135.5 (82.1)0.2410.790Hemolysis (%), mean (SD)Site 10.33 (0.34)0.32 (0.34)0.30 (0.15)0.050.855Site 20.34 (0.13)0.31 (0.16)0.31 (0.19)0.3630.995Osmotic FragilityOsmotic fragility was measured as percent hemolysis in 0.55% saline at Site and as the percent saline at >= 50% hemolysis at Site 2. Site 120.0 (14.4)19.6 (15.2)31.0 (22.3)0.8850.152Site 20.51 (0.03)0.51 (0.03)0.49 (0.02)0.9350.009The primary outcome of this study was to demonstrate RBC collection, storage, and viability in vitro.The sRBC and dRBC units collected were comparable. The hematocrits, blood gasses, ATP, potassium, total hemoglobin, and osmotic fragility were within acceptable ranges following storage. Two statistically significant differences were identified between the and units in the dRBC collection at Day 42 (sodium and plasma free hemoglobin), but these differences were not clinically significant. There was no difference between dRBC units in hemolysis following storage in ADDITIVE SOLUTION FORMULA (AS-3). statistically significant difference was identified in the osmotic fragility of RBCs stored in ADDITIVE SOLUTION FORMULA (AS-3) following sRBC collection or dRBC collection at Day 42, but the difference was not clinically significant. All the RBC units collected averaged less than 1% hemolysis on Day 42. These results are consistent with US and European guidelines for hemolysis on transfusion. ATP recovery was greater than 70% of all units, which is predictive of good in vivo viability, and potassium levels on Day 42 average less than 50 mEq/L indicating good RBC membrane stability over the storage period.

CONTRAINDICATIONS SECTION.

4 CONTRAINDICATIONS. DO NOT INFUSE ADDITIVE SOLUTION FORMULA (AS-3) DIRECTLY TO THE DONOR.. DO NOT INFUSE AS-3 DIRECTLY TO THE DONOR. (4) DO NOT INFUSE AS-3 DIRECTLY TO THE DONOR. (4).

DESCRIPTION SECTION.

11 DESCRIPTION. ADDITIVE SOLUTION FORMULA (AS-3) is designed to be added to packed RBC collected in apheresis procedures, and acts to preserve and extend the shelf life of packed RBC products for later transfusion to patients. The solution is intended to be metered by an apheresis device during apheresis procedures or added manually after collection.Additive Solution Formula (AS-3) is clear solution that is steam-sterilized and non-pyrogenic. It does not contain bacteriostatic or antimicrobial agents. The formulas of the active ingredients are provided in Table 1.Table 1: Active IngredientsIngredientsMolecular FormulaMolecular WeightDextrose Monohydrate USPC6H12O6 H2O198.17Trisodium Citrate Dihydrate USPC6H9Na3O9 294.10Sodium Chloride USPNaCl58.44Monobasic Sodium Phosphate Monohydrate USPNaH2PO4 H2O137.99Citric Acid Monohydrate USPC6H807 H2O210.14Adenine USPC5H5N5 135.13Water for Injection USPH2O18.00Each 100 mL of ADDITIVE SOLUTION FORMULA (AS-3) contains: Dextrose Monohydrate USP 1.10 g; Trisodium Citrate Dihydrate USP 0.59 g; Sodium Chloride USP 0.41 g; Monobasic Sodium Phosphate Monohydrate USP 0.28 g; Citric Acid Monohydrate USP 0.042 g; Adenine USP 0.03 g; and Water for Injection USP.ADDITIVE SOLUTION FORMULA is available in three volumes: 100 mL, 200 mL and 350 mL.The 100 mL bags are individually wrapped with clear plastic film. Six individually wrapped bags are then vacuum-sealed in foil pouch, which serves as vapor barrier to prevent water loss during storage. After you remove the individual solution bags from the foil pouch, you can either leave them in the clear plastic film or remove and discard it. Once the foil pouch has been opened, use all six of the solution bags within weeks.The 200 mL and 350 mL bags are individually wrapped with clear plastic film. These larger volumes do not require the additional vapor barrier. Once the clear plastic film has been removed, use the solution within weeks.The Polyolefin bag is not made with natural rubber latex.The bag is made from multilayered film. It contains materials that have been tested to demonstrate the suitability of the container for storing pharmaceutical solutions. The bag is nontoxic and biologically inert. The bag-solution unit is closed system and is not dependent upon entry of external air during administration.

DOSAGE & ADMINISTRATION SECTION.

2 DOSAGE AND ADMINISTRATION. AS-3 is added to tubing sets after apheresis collections, after the donor has been disconnected. (2)AS-3 may only be used with the Trima Accel apheresis device. For instructions on the use of the solution see the device operators manual. (2.1)Follow the directions for connecting the AS-3 bag to the tubing set of blood collection system. (2.2). AS-3 is added to tubing sets after apheresis collections, after the donor has been disconnected. (2). AS-3 may only be used with the Trima Accel apheresis device. For instructions on the use of the solution see the device operators manual. (2.1). Follow the directions for connecting the AS-3 bag to the tubing set of blood collection system. (2.2). 2.1 General Dosing Information. ADDITIVE SOLUTION FORMULA (AS-3) is connected to the tubing set used for an apheresis RBC collection procedure after the collection has been completed.For automated RBC procedures, the recommended dose is determined by the apheresis device and metered into the tubing set by the apheresis device.To add the product manually, refer to the apheresis system operators manual to determine the recommended dose.For instructions on the use of the solution with the apheresis device and tubing set, see the device operators manual.. For automated RBC procedures, the recommended dose is determined by the apheresis device and metered into the tubing set by the apheresis device.. To add the product manually, refer to the apheresis system operators manual to determine the recommended dose.. 2.2 Administration. Directions for connecting the ADDITIVE SOLUTION FORMULA (AS-3) bag to the apheresis device. Automated RBC additive solution procedures:Connect ADDITIVE SOLUTION FORMULA (AS-3) after the collection is over and the donor is disconnected. For automated addition of the product, the system will prompt you to connect the bag.Remove the overwrap by pulling down at notch, and remove the AS-3 bag.Before use, perform the following checks:Ensure that the solution is the ADDITIVE SOLUTION FORMULA (AS-3) and is within the expiration date.Inspect the bag in good light. Do not use if the container is damaged, leaking or if there is any visible sign of deterioration. Check for leaks by gently squeezing the bag. If leaks are found, discard the bag.Inspect the solution in good light. Use only if solution is clear and free of particulate matter. Bags showing cloudiness, haze, or particulate matter should not be used.Protect from sharp objects. Remove the protective cap from the port on the bag.Connect the bag to the complementary luer of the apheresis device tubing set using aseptic technique and hang the solution.Break the frangible connector. When you break frangible connectors, bend them in both directions to ensure that you break them completely. Failure to do so may result in restricted flow.Proceed according to the apheresis device operators manual.. Remove the overwrap by pulling down at notch, and remove the AS-3 bag.. Before use, perform the following checks:Ensure that the solution is the ADDITIVE SOLUTION FORMULA (AS-3) and is within the expiration date.Inspect the bag in good light. Do not use if the container is damaged, leaking or if there is any visible sign of deterioration. Check for leaks by gently squeezing the bag. If leaks are found, discard the bag.Inspect the solution in good light. Use only if solution is clear and free of particulate matter. Bags showing cloudiness, haze, or particulate matter should not be used.Protect from sharp objects. Ensure that the solution is the ADDITIVE SOLUTION FORMULA (AS-3) and is within the expiration date.. Inspect the bag in good light. Do not use if the container is damaged, leaking or if there is any visible sign of deterioration. Check for leaks by gently squeezing the bag. If leaks are found, discard the bag.. Inspect the solution in good light. Use only if solution is clear and free of particulate matter. Bags showing cloudiness, haze, or particulate matter should not be used.. Protect from sharp objects.. Remove the protective cap from the port on the bag.. Connect the bag to the complementary luer of the apheresis device tubing set using aseptic technique and hang the solution.. Break the frangible connector. When you break frangible connectors, bend them in both directions to ensure that you break them completely. Failure to do so may result in restricted flow.. Proceed according to the apheresis device operators manual.. Manual RBC additive solution procedures:Connect ADDITIVE SOLUTION FORMULA (AS-3) after the collection is over and the donor is disconnected. Seal the RBC product lines as close to the cassette as possible.Remove the overwrap by pulling down at notch, and remove the ADDITIVE SOLUTION FORMULA bag.Before use, perform the following checks:Ensure that the solution is the ADDITIVE SOLUTION FORMULA (AS-3) and is within the expiration date.Inspect the bag in good light. Do not use if the container is damaged, leaking or if there is any visible sign of deterioration. Check for leaks by gently squeezing the bag. If leaks are found, discard the bag.Inspect the solution in good light. Use only if solution is clear and free of particulate matter. Bags showing cloudiness, haze, or particulate matter should not be used.Protect from sharp objects. Remove the protective cap from the port on the bag.Insert the spike of the apheresis device tubing set into the spike port of the solution bag using aseptic technique and then hang the solution.Proceed according to the apheresis device operators manual.. Seal the RBC product lines as close to the cassette as possible.. Remove the overwrap by pulling down at notch, and remove the ADDITIVE SOLUTION FORMULA bag.. Before use, perform the following checks:Ensure that the solution is the ADDITIVE SOLUTION FORMULA (AS-3) and is within the expiration date.Inspect the bag in good light. Do not use if the container is damaged, leaking or if there is any visible sign of deterioration. Check for leaks by gently squeezing the bag. If leaks are found, discard the bag.Inspect the solution in good light. Use only if solution is clear and free of particulate matter. Bags showing cloudiness, haze, or particulate matter should not be used.Protect from sharp objects. Ensure that the solution is the ADDITIVE SOLUTION FORMULA (AS-3) and is within the expiration date.. Inspect the bag in good light. Do not use if the container is damaged, leaking or if there is any visible sign of deterioration. Check for leaks by gently squeezing the bag. If leaks are found, discard the bag.. Inspect the solution in good light. Use only if solution is clear and free of particulate matter. Bags showing cloudiness, haze, or particulate matter should not be used.. Protect from sharp objects.. Remove the protective cap from the port on the bag.. Insert the spike of the apheresis device tubing set into the spike port of the solution bag using aseptic technique and then hang the solution.. Proceed according to the apheresis device operators manual.

DOSAGE FORMS & STRENGTHS SECTION.

3 DOSAGE FORMS AND STRENGTHS. 100 mL, 200 mL and 350 mL ADDITIVE SOLUTION FORMULA (AS-3) products are sterile solutions in Polyolefin bag. Each 100 mL contains: Dextrose Monohydrate USP 1.10 g; Trisodium Citrate Dihydrate USP 0.59 g; Sodium Chloride USP 0.41 g; Monobasic Sodium Phosphate Monohydrate USP 0.28 g; Citric Acid Monohydrate USP 0.042 g; Adenine USP 0.03 g; and Water for Injection USP.. 100 mL, 200 mL, or 350 mL sterile fluid in Polyolefin bag. (3). 100 mL, 200 mL, or 350 mL sterile fluid in Polyolefin bag. (3).

HOW SUPPLIED SECTION.

16 HOW SUPPLIED/STORAGE AND HANDLING. ADDITIVE SOLUTION FORMULA (AS-3) is clear solution supplied in sterile and non-pyrogenic Polyolefin bags.SIZECATALOG NUMBERNDC NUMBERQUANTITY PER CASE100 mL4083214537-832-0336200 mL4083314537-833-0330350 mL4083414537-834-0324. STORAGEUp to 25 C.Protect from freezing.

INDICATIONS & USAGE SECTION.

1 INDICATIONS AND USAGE. Use only with Trima Accel red blood cell (RBC) apheresis collections. [See Dosage and Administration (2).] Use only with Trima Accel red blood cell (RBC) apheresis collections. (1).

MECHANISM OF ACTION SECTION.

12.1 Mechanism of Action. ADDITIVE SOLUTION FORMULA acts to preserve and extend the shelf life of packed RBC products for later transfusion to patients. The following ingredients are key components of the solution:Adenine to support adenosine triphosphate (ATP) levelsCitrate for membrane protection, anticoagulation and pH regulationSodium (Sodium Chloride and Sodium Citrate) and dextrose for isotonicityDextrose for RBC nutritionThis solution has no pharmacological effect.. Adenine to support adenosine triphosphate (ATP) levels. Citrate for membrane protection, anticoagulation and pH regulation. Sodium (Sodium Chloride and Sodium Citrate) and dextrose for isotonicity. Dextrose for RBC nutrition.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL 100 mL Bag Pouch Case Label. Additive Solution Formula (AS-3)Catalog 40832 Polyolefin Bag x x 100 mL unitsNDC 14537-832-03Manufactured by TERUMO BCT, INC.10811 W. Collins Ave.,Lakewood CO 80215, USAMade in UKLPN 1000005747Use only with Trima Accel red blood cell apheresis collections. Seeapheresis device operators manual for complete instructions. Read thepackage insert before use. Sterile. Non-pyrogenic. Sterilized with steam.Caution: Do not use if the bag is damaged. Use only if solution is clearand free of particulate matter. Single use bag. Discard any unusedproduct. Not for direct intravenous infusion. Rx Only.Recommended storage: Up to 25C. Protect from freezing. Each 100 mL contains: Dextrose Monohydrate USP 1.10 Trisodium Citrate Dihydrate USP 0.588 Sodium Chloride USP 0.410 Monobasic Sodium Phosphate Monohydrate USP0.276 Citric Acid Monohydrate USP0.042 Adenine USP 0.030 gIn Water for Injection USPLotExpiry Date. PRINCIPAL DISPLAY PANEL 100 mL Bag Pouch Case Label.

SPL UNCLASSIFIED SECTION.

2.1 General Dosing Information. ADDITIVE SOLUTION FORMULA (AS-3) is connected to the tubing set used for an apheresis RBC collection procedure after the collection has been completed.For automated RBC procedures, the recommended dose is determined by the apheresis device and metered into the tubing set by the apheresis device.To add the product manually, refer to the apheresis system operators manual to determine the recommended dose.For instructions on the use of the solution with the apheresis device and tubing set, see the device operators manual.. For automated RBC procedures, the recommended dose is determined by the apheresis device and metered into the tubing set by the apheresis device.. To add the product manually, refer to the apheresis system operators manual to determine the recommended dose.

STORAGE AND HANDLING SECTION.

STORAGEUp to 25 C.Protect from freezing.

USE IN SPECIFIC POPULATIONS SECTION.

8 USE IN SPECIFIC POPULATIONS. ADDITIVE SOLUTION FORMULA (AS-3) has not been studied in controlled clinical trials with specific populations.

WARNINGS AND PRECAUTIONS SECTION.

5 WARNINGS AND PRECAUTIONS. Verify that the AS-3 bag has been securely attached to the system tubing set. Use aseptic technique throughout all procedures to ensure product quality.Do not reuse. Discard unused or partially used solution bags.. Verify that the AS-3 bag has been securely attached to the system tubing set. Use aseptic technique throughout all procedures to ensure product quality.. Do not reuse. Discard unused or partially used solution bags.. Verify that the AS-3 bag has been securely attached to the system tubing set. Use aseptic technique throughout all procedures to ensure product quality. (5)Do not reuse. Discard unused or partially used solution bags.. Verify that the AS-3 bag has been securely attached to the system tubing set. Use aseptic technique throughout all procedures to ensure product quality. (5). Do not reuse. Discard unused or partially used solution bags.