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Questions and Answers on USP 797

Questions and Answers on USP 797: Answers Provided by Eric S. Kastango, MBA, RPh, FASHP:

  • E30 Question: I’m working in a warehouse with controlled temperature and we have a little problem with this control. We have 4 temperatures chambers now, and they are: Ambient (8 to 30 ºC), Cold (2 to 8 ºC), Freezer (-20 to -30 ºC) and Ultra-Freezer (<-65ºC). The equipments works well enough, but (sometimes) there is a little excursion and this is a great problem to solve it.My question is: Is there any USP Standard data about excursions of these ranges? We are looking for something similar to this for each range: “Standard cold room is between 2 & 8ºC, but excursions between 0 and 15ºC up to 12 hours are allowed”.
     
  • E30 Answer: 

    If you refer to USP General Notices section on Storage you will find the following:

    PRESERVATION, PACKAGING, STORAGE, AND LABELING

    Containers— The container is that which holds the article and is or may be in direct contact with the article. The immediate container is that which is in direct contact with the article at all times. The closure is a part of the container.

    Prior to being filled, the container should be clean. Special precautions and cleaning procedures may be necessary to ensure that each container is clean and that extraneous matter is not introduced into or onto the article.

    The container does not interact physically or chemically with the article placed in it so as to alter the strength, quality, or purity of the article beyond the official requirements.

    The Pharmacopeial requirements for the use of specified containers apply also to articles as packaged by the pharmacist or other dispenser, unless otherwise indicated in the individual monograph.

    Tamper-Evident Packaging — The container or individual carton of a sterile article intended for ophthalmic or otic use, except where extemporaneously compounded for immediate dispensing on prescription, shall be so sealed that the contents cannot be used without obvious destruction of the seal.

    Articles intended for sale without prescription are also required to comply with the tamper-evident packaging and labeling requirements of the FDA where applicable.

    Preferably, the immediate container and/or the outer container or protective packaging used by a manufacturer or distributor for all dosage forms that are not specifically exempt is designed so as to show evidence of any tampering with the contents.

    Light-Resistant Container (see Light Transmission under Containers http://www.uspnf.com/uspnf/pub/data/v30252/usp30nf25s2_c661.xml#usp30nf25s2_c661661http://www.uspnf.com/uspnf/pub/data/v30252/usp30nf25s2_c661.xml#usp30nf25s2_c661)— A light-resistant container protects the contents from the effects of light by virtue of the specific properties of the material of which it is composed, including any coating applied to it. Alternatively, a clear and colorless or a translucent container may be made light-resistant by means of an opaque covering, in which case the label of the container bears a statement that the opaque covering is needed until the contents are to be used or administered. Where it is directed to “protect from light” in an individual monograph, preservation in a light-resistant container is intended.

    Where an article is required to be packaged in a light-resistant container, and if the container is made light-resistant by means of an opaque covering, a single-use, unit-dose container or mnemonic pack for dispensing may not be removed from the outer opaque covering prior to dispensing.

    Well-Closed Container— A well-closed container protects the contents from extraneous solids and from loss of the article under the ordinary or customary conditions of handling, shipment, storage, and distribution.

    Tight Container—A tight container protects the contents from contamination by extraneous liquids, solids, or vapors; from loss of the article; and from efflorescence, deliquescence, or evaporation under the ordinary or customary conditions of handling, shipment, storage, and distribution; and is capable of tight reclosure. Where a tight container is specified, it may be replaced by a hermetic container for a single dose of an article.

    A gas cylinder is a metallic container designed to hold a gas under pressure. As a safety measure, for carbon dioxide, cyclopropane, helium, nitrous oxide, and oxygen, the Pin-Index Safety System of matched fittings is recommended for cylinders of Size E or smaller.

    NOTE—Where packaging and storage in a tight container or a well-closed container is specified in the individual monograph, the container used for an article when dispensed on prescription meets the requirements under Containers—Permeation http://www.uspnf.com/uspnf/pub/data/v30252/usp30nf25s2_c671.xml#usp30nf25s2_c671671http://www.uspnf.com/uspnf/pub/data/v30252/usp30nf25s2_c671.xml#usp30nf25s2_c671.

    Hermetic Container— A hermetic container is impervious to air or any other gas under the ordinary or customary conditions of handling, shipment, storage, and distribution.

    Single-Unit Container—A single-unit container is one that is designed to hold a quantity of drug product intended for administration as a single dose or a single finished device intended for use promptly after the container is opened. Preferably, the immediate container and/or the outer container or protective packaging shall be so designed as to show evidence of any tampering with the contents. Each single-unit container shall be labeled to indicate the identity, quantity and/or strength, name of the manufacturer, lot number, and expiration date of the article.

    Single-Dose Container (see also Containers for Injections under Injections http://www.uspnf.com/uspnf/pub/data/v30252/usp30nf25s2_c1.xml#usp30nf25s2_c11http://www.uspnf.com/uspnf/pub/data/v30252/usp30nf25s2_c1.xml#usp30nf25s2_c1)—A single-dose container is a single-unit container for articles intended for parenteral administration only. A single-dose container is labeled as such. Examples of single-dose containers include prefilled syringes, cartridges, fusion-sealed containers, and closure-sealed containers when so labeled.

    Unit-Dose Container—A unit-dose container is a single-unit container for articles intended for administration by other than the parenteral route as a single dose, direct from the container.

    Unit-of-Use Container—A unit-of-use container is one that contains a specific quantity of a drug product and that is intended to be dispensed as such without further modification except for the addition of appropriate labeling. A unit-of-use container is labeled as such.

    Multiple-Unit Container—A multiple-unit container is a container that permits withdrawal of successive portions of the contents without changing the strength, quality, or purity of the remaining portion.

    Multiple-Dose Container (see also Containers for Injections under Injections http://www.uspnf.com/uspnf/pub/data/v30252/usp30nf25s2_c1.xml#usp30nf25s2_c11http://www.uspnf.com/uspnf/pub/data/v30252/usp30nf25s2_c1.xml#usp30nf25s2_c1)— A multiple-dose container is a multiple-unit container for articles intended for parenteral administration only.

    Poison Prevention Packaging Act— This act (see the Website, www.cpsc.gov/businfo/pppa.html) requires special packaging of most human oral prescription drugs, oral controlled drugs, certain nonoral prescription drugs, certain dietary supplements, and many over-the-counter (OTC) drug preparations in order to protect the public from personal injury or illness from misuse of these preparations (16 CFR § 1700.14).

    The immediate packaging of substances regulated under the PPPA must comply with the special packaging standards (16 CFR § 1700.15 and 16 CFR § 1700.20). The PPPA regulations for special packaging apply to all packaging types including reclosable, nonclosable, and unit-dose types.

    Special packaging is not required for drugs dispensed within a hospital setting for inpatient administration. Manufacturers and packagers of bulk-packaged prescription drugs do not have to use special packaging if the drug will be repackaged by the pharmacist. PPPA-regulated prescription drugs may be dispensed in nonchild-resistant packaging upon the request of the purchaser or when directed in a legitimate prescription (15 U.S.C. § 1473).

    Manufacturers or packagers of PPPA-regulated OTC preparations are allowed to package one size in nonchild-resistant packaging as long as popular-size, special packages are also supplied. The nonchild-resistant package requires special labeling (18 CFR § 1700.5).

    Various types of child-resistant packages are covered in ASTM International Standard D-3475, Standard Classification of Child-Resistant Packaging. Examples are included as an aid in the understanding and comprehension of each type of classification.

    Storage Temperature and Humidity— Specific directions are stated in some monographs with respect to the temperatures and humidity at which Pharmacopeial articles shall be stored and distributed (including the shipment of articles to the consumer) when stability data indicate that storage and distribution at a lower or a higher temperature and a higher humidity produce undesirable results. Such directions apply except where the label on an article states a different storage temperature on the basis of stability studies of that particular formulation. Where no specific storage directions or limitations are provided in the individual monograph, but the label of an article states a storage temperature that is based on stability studies of that particular formulation, such labeled storage directions apply (see also Pharmaceutical Stability http://www.uspnf.com/uspnf/pub/data/v30252/usp30nf25s2_c1150.xml#usp30nf25s2_c11501150http://www.uspnf.com/uspnf/pub/data/v30252/usp30nf25s2_c1150.xml#usp30nf25s2_c1150). The conditions are defined by the following terms.

    Freezer— A place in which the temperature is maintained thermostatically between 25 and 10 (13 and 14 F).

    Cold— Any temperature not exceeding 8 (46 F). A refrigerator is a cold place in which the temperature is maintained thermostatically between 2 and 8 (36 and 46 F).

    Cool— Any temperature between 8 and 15 (46 and 59 F). An article for which storage in a cool place is directed may, alternatively, be stored and distributed in a refrigerator, unless otherwise specified by the individual monograph.

    Controlled Cold Temperature— This temperature is defined as the temperature maintained thermostatically between 2 and 8 (36 and 46 F), that allows for excursions in temperature between 0 and 15 (32 and 59 F) that may be experienced during storage, shipping, and distribution such that the allowable calculated MKT is not more than 8 (46 F). Transient spikes up to 25 (77 F) may be permitted if the manufacturer so instructs and provided that such spikes do not exceed 24 hours unless supported by stability data or the manufacturer instructs otherwise.

    Room Temperature— The temperature prevailing in a working area.

    Controlled Room Temperature— A temperature maintained thermostatically that encompasses the usual and customary working environment of 20 to 25 (68 to 77 F); that results in a mean kinetic temperature calculated to be not more than 25; and that allows for excursions between 15 and 30 (59 and 86 F) that are experienced in pharmacies, hospitals, and warehouses. Provided the mean kinetic temperature remains in the allowed range, transient spikes up to 40 are permitted as long as they do not exceed 24 hours. Spikes above 40 may be permitted if the manufacturer so instructs. Articles may be labeled for storage at “controlled room temperature” or at “up to 25”, or other wording based on the same mean kinetic temperature. The mean kinetic temperature is a calculated value that may be used as an isothermal storage temperature that simulates the nonisothermal effects of storage temperature variations. (See also Pharmaceutical Stability http://www.uspnf.com/uspnf/pub/data/v30252/usp30nf25s2_c1150.xml#usp30nf25s2_c11501150http://www.uspnf.com/uspnf/pub/data/v30252/usp30nf25s2_c1150.xml#usp30nf25s2_c1150.)

    An article for which storage at Controlled Room Temperature is directed may, alternatively, be stored and distributed in a cool place, unless otherwise specified in the individual monograph or on the label.

    Warm— Any temperature between 30 and 40 (86 and 104 F).

    Excessive Heat— Any temperature above 40 (104 F).

    Protection from Freezing— Where, in addition to the risk of breakage of the container, freezing subjects an article to loss of strength or potency, or to destructive alteration of its characteristics, the container label bears an appropriate instruction to protect the article from freezing.

    Dry Place— The term “dry place” denotes a place that does not exceed 40% average relative humidity at Controlled Room Temperature or the equivalent water vapor pressure at other temperatures. The determination may be made by direct measurement at the place or may be based on reported climatic conditions. Determination is based on not less than 12 equally spaced measurements that encompass either a season, a year, or, where recorded data demonstrate, the storage period of the article. There may be values of up to 45% relative humidity provided that the average value is 40% relative humidity.

    Storage in a container validated to protect the article from moisture vapor, including storage in bulk, is considered a dry place.

    Storage under Nonspecific Conditions— Where no specific directions or limitations are provided in the Packaging and storage section of individual monographs or in the article's labeling, the conditions of storage shall include storage at controlled room temperature, protection from moisture, and, where necessary, protection from light. Articles shall be protected from moisture, freezing, and excessive heat, and, where necessary, from light during shipping and distribution. Active pharmaceutical ingredients are exempt from this requirement.

    Labeling—The term “labeling” designates all labels and other written, printed, or graphic matter upon an immediate container of an article or upon, or in, any package or wrapper in which it is enclosed, except any outer shipping container. The term “label” designates that part of the labeling upon the immediate container.

    A shipping container containing a single article, unless such container is also essentially the immediate container or the outside of the consumer package, is labeled with a minimum of product identification (except for controlled articles), lot number, expiration date, and conditions for storage and distribution.

    Articles in this Pharmacopeia are subject to compliance with such labeling requirements as may be promulgated by governmental bodies in addition to the Pharmacopeial requirements set forth for the articles.

    Amount of Ingredient per Dosage Unit— The strength of a drug product is expressed on the container label in terms of micrograms or milligrams or grams or percentage of the therapeutically active moiety or drug substance, whichever form is used in the title, unless otherwise indicated in an individual monograph. Both the active moiety and drug substance names and their equivalent amounts are then provided in the labeling.

    Pharmacopeial articles in capsule, tablet, or other unit dosage form shall be labeled to express the quantity of each active ingredient or recognized nutrient contained in each such unit; except that, in the case of unit-dose oral solutions or suspensions, whether supplied as liquid preparations or as liquid preparations that are constituted from solids upon addition of a designated volume of a specific diluent, the label shall express the quantity of each active ingredient or recognized nutrient delivered under the conditions prescribed in Deliverable Volume http://www.uspnf.com/uspnf/pub/data/v30252/usp30nf25s2_c698.xml#usp30nf25s2_c698698http://www.uspnf.com/uspnf/pub/data/v30252/usp30nf25s2_c698.xml#usp30nf25s2_c698. Pharmacopeial drug products not in unit dosage form shall be labeled to express the quantity of each active ingredient in each milliliter or in each gram, or to express the percentage of each such ingredient (see Percentage Measurements), except that oral liquids or solids intended to be constituted to yield oral liquids may, alternatively, be labeled in terms of each 5-mL portion of the liquid or resulting liquid. Unless otherwise indicated in a monograph or chapter, such declarations of strength or quantity shall be stated only in metric units (see also Units of Potency in these General Notices).

    Use of Leading and Terminal Zeros— In order to help minimize the possibility of errors in the dispensing and administration of drugs, the quantity of active ingredient when expressed in whole numbers shall be shown without a decimal point that is followed by a terminal zero (e.g., express as 4 mg [not 4.0 mg]). The quantity of active ingredient when expressed as a decimal number smaller than 1 shall be shown with a zero preceding the decimal point (e.g., express as 0.2 mg [not .2 mg]).

    Labeling of Salts of Drugs—It is an established principle that Pharmacopeial articles shall have only one official name. For purposes of saving space on labels, and because chemical symbols for the most common inorganic salts of drugs are well known to practitioners as synonymous with the written forms, the following alternatives are permitted in labeling official articles that are salts: HCl for hydrochloride; HBr for hydrobromide; Na for sodium; and K for potassium. The symbols Na and K are intended for use in abbreviating names of the salts of organic acids; but these symbols are not used where the word Sodium or Potassium appears at the beginning of an official title (e.g., Phenobarbital Na is acceptable, but Na Salicylate is not to be written).

    Labeling Vitamin-Containing Products—The vitamin content of an official drug product shall be stated on the label in metric units per dosage unit. The amounts of vitamins A, D, and E may be stated also in USP Units. Quantities of vitamin A declared in metric units refer to the equivalent amounts of retinol (vitamin A alcohol). The label of a nutritional supplement shall bear an identifying lot number, control number, or batch number.

    Labeling Botanical-Containing Products—The label of an herb or other botanical intended for use as a dietary supplement bears the statement, “If you are pregnant or nursing a baby, seek the advice of a health professional before using this product.”

    Labeling Parenteral and Topical Preparations— The label of a preparation intended for parenteral or topical use states the names of all added substances (see Added Substances in these General Notices and Requirements, and see Labeling under Injections http://www.uspnf.com/uspnf/pub/data/v30252/usp30nf25s2_c1.xml#usp30nf25s2_c11http://www.uspnf.com/uspnf/pub/data/v30252/usp30nf25s2_c1.xml#usp30nf25s2_c1), and, in the case of parenteral preparations, also their amounts or proportions, except that for substances added for adjustment of pH or to achieve isotonicity, the label may indicate only their presence and the reason for their addition.

    Labeling Electrolytes—The concentration and dosage of electrolytes for replacement therapy (e.g., sodium chloride or potassium chloride) shall be stated on the label in milliequivalents (mEq). The label of the product shall indicate also the quantity of ingredient(s) in terms of weight or percentage concentration.

    Labeling Alcohol— The content of alcohol in a liquid preparation shall be stated on the label as a percentage (v/v) of C2H5OH.

    Special Capsules and Tablets—The label of any form of Capsule or Tablet intended for administration other than by swallowing intact bears a prominent indication of the manner in which it is to be used.

    Expiration Date and Beyond-Use Date—The label of an official drug product or nutritional or dietary supplement product shall bear an expiration date. All articles shall display the expiration date so that it can be read by an ordinary individual under customary conditions of purchase and use. The expiration date shall be prominently displayed in high contrast to the background or sharply embossed, and easily understood (e.g., “EXP 6/89,” “Exp. June 89,” or “Expires 6/89”). [NOTE—For additional information and guidance, refer to the Nonprescription Drug Manufacturers Association's Voluntary Codes and Guidelines of the OTC Medicines Industry.]

    The monographs for some preparations state how the expiration date that shall appear on the label is to be determined. In the absence of a specific requirement in the individual monograph for a drug product or nutritional supplement, the label shall bear an expiration date assigned for the particular formulation and package of the article, with the following exception: the label need not show an expiration date in the case of a drug product or nutritional supplement packaged in a container that is intended for sale without prescription and the labeling of which states no dosage limitations, and which is stable for not less than 3 years when stored under the prescribed conditions.

    Where an official article is required to bear an expiration date, such article shall be dispensed solely in, or from, a container labeled with an expiration date, and the date on which the article is dispensed shall be within the labeled expiry period. The expiration date identifies the time during which the article may be expected to meet the requirements of the Pharmacopeial monograph, provided it is kept under the prescribed storage conditions. The expiration date limits the time during which the article may be dispensed or used. Where an expiration date is stated only in terms of the month and the year, it is a representation that the intended expiration date is the last day of the stated month. The beyond-use date is the date after which an article must not be used. The dispenser shall place on the label of the prescription container a suitable beyond-use date to limit the patient's use of the article based on any information supplied by the manufacturer and the General Notices and Requirements of this Pharmacopeia. The beyond-use date placed on the label shall not be later than the expiration date on the manufacturer's container.

    For articles requiring constitution prior to use, a suitable beyond-use date for the constituted product shall be identified in the labeling.

    For all other dosage forms, in determining an appropriate period of time during which a prescription drug may be retained by a patient after its dispensing, the dispenser shall take into account, in addition to any other relevant factors, the nature of the drug; the container in which it was packaged by the manufacturer and the expiration date thereon; the characteristics of the patient's container, if the article is repackaged for dispensing; the expected storage conditions to which the article may be exposed; any unusual storage conditions to which the article may be exposed; and the expected length of time of the course of therapy. The dispenser shall, on taking into account the foregoing, place on the label of a multiple-unit container a suitable beyond-use date to limit the patient's use of the article. Unless otherwise specified in the individual monograph, or in the absence of stability data to the contrary, such beyond-use date shall be not later than (a) the expiration date on the manufacturer's container, or (b) 1 year from the date the drug is dispensed, whichever is earlier. For nonsterile solid and liquid dosage forms that are packaged in single-unit and unit-dose containers, the beyond-use date shall be 1 year from the date the drug is packaged into the single-unit or unit-dose container or the expiration date on the manufacturer’s container, whichever is earlier, unless stability data or the manufacturer’s labeling indicates otherwise.

    The dispenser must maintain the facility where the dosage forms are packaged and stored, at a temperature such that the mean kinetic temperature is not greater than 25. The plastic material used in packaging the dosage forms must afford better protection than polyvinyl chloride, which does not provide adequate protection against moisture permeation. Records must be kept of the temperature of the facility where the dosage forms are stored, and of the plastic materials used in packaging.

    Pharmaceutical Compounding— The label on the container or package of an official compounded preparation shall bear a beyond-use date. The beyond-use date is the date after which a compounded preparation is not to be used. Because compounded preparations are intended for administration immediately or following short-term storage, their beyond-use dates may be assigned based on criteria different from those applied to assigning expiration dates to manufactured drug products.

    The monograph for an official compounded preparation typically includes a beyond-use requirement that states the time period following the date of compounding during which the preparation, properly stored, is to be used. In the absence of stability information that is applicable to a specific drug and preparation, recommendations for maximum beyond-use dates have been devised for nonsterile compounded drug preparations that are packaged in tight, light-resistant containers and stored at controlled room temperature unless otherwise indicated (see Stability Criteria and Beyond-Use Dating under Stability of Compounded Preparations in the general tests chapter Pharmaceutical Compounding—Nonsterile Preparations http://www.uspnf.com/uspnf/pub/data/v30252/usp30nf25s2_c795.xml#usp30nf25s2_c795795http://www.uspnf.com/uspnf/pub/data/v30252/usp30nf25s2_c795.xml#usp30nf25s2_c795).

    Guidelines for Packaging and Storage Statements in USP–NF Monographs— In order to provide users of the USP–NF with proper guidance on how to package and store compendial articles, every monograph in the USP–NF is required to have a packaging and storage specification.

    For those instances where, for some reason, storage information is not yet found in the Packaging and storage specification of a monograph, the section Storage Under Nonspecific Conditions is included in the General Notices as interim guidance. The Storage Under Nonspecific Conditions statement is not meant to substitute for the inclusion of proper, specific storage information in the Packaging and storage statement of any monograph.

    For the packaging portion of the statement, the choice of containers is given in the General Notices and includes Light-Resistant Container, Well-Closed Container, Tight Container, Hermetic Container, Single-Unit Container, Single-Dose Container, Unit-Dose Container, and Unit-of-Use Container. For most preparations, the choice is determined by the container in which it is to be dispensed (e.g., tight, well-closed, hermetic, unit-of-use, etc). For active pharmaceutical ingredients (APIs), the choice would appear to be tight, well-closed, or, where needed, a light-resistant container. For excipients, given their typical nature as large-volume commodity items, with containers ranging from drums to tank cars, a well-closed container is an appropriate default. Therefore, in the absence of data indicating a need for a more protective class of container, the phrase “Preserve in well-closed containers” should be used as a default for excipients.

    For the storage portion of the statement, the choice of storage temperatures presented in the General Notices includes Freezer, Cold, Cool, Controlled Cold Temperature, Room Temperature, Controlled Room Temperature, Warm, Excessive Heat, and Protection from Freezing. The definition of a dry place is provided if protection from humidity is important.

    For most preparations, the choice is determined by the experimentally determined stability of the preparation and may include any of the previously stated storage conditions as determined by the manufacturer. For APIs that are expected to be retested before incorporation into a preparation, a more general and nonrestrictive condition may be desired. In this case, the specification “room temperature” (the temperature prevailing in a working area) should suffice. The use of the permissive room temperature condition reflects the stability of an article over a wide temperature range. For excipients, the phrase “No storage requirements specified” in the Packaging and storage statement of the monograph would be appropriate.

    Because most APIs in the USP–NF have associated Reference Standards, special efforts should be considered to ensure that the Reference Standards' storage conditions correspond to the conditions indicated in the USP–NF monographs.

    The Packaging and Storage Expert Committee may review questionable Packaging and storage statements on a case-by-case basis. In cases where the Packaging and storage statements are incomplete, the monographs would move forward to publication while the Packaging and storage statements are temporarily deferred.

     

(Answer provided as a courtesty to usp797.org, inc. by Eric S. Kastango, MBA, RPh, FASHP. Please note that usp797.org, inc. is not responsible for this answer.)

  • About Eric S. Kastango: Since its inception, Eric S. Kastango has been at the forefront of USP <797>. He is an elected member of the United States Pharmacopoeia Sterile Compounding Committee (2005-2010). Over the years, he has held multiple American Society of Health-System Pharmacists chairmanships and committee positions. He was responsible for creating the “Comprehensive Sterile Compounding Compliance Gap Analysis and Risk Assessment Tool.” In this capacity, Mr. Kastango frequents pharmacy events as an expert speaker, contributes to industry journals, and teaches. Mr. Kastango received his Bachelor of Science in Pharmacy degree from the Massachusetts College of Pharmacy and Allied Health Sciences and a MBA from the University of Phoenix. Since 1980, he has practiced pharmacy in a number of practice settings (including hospitals, community, and home care) in a number of different of roles, including the Corporate Vice President of Pharmacy Services for Coram Healthcare Corporation, which has 72 pharmacies in 44 states. He has also managed a FDA-registered cGMP manufacturing operation for Baxter Healthcare Corporation, and has made over 100 presentations on a variety of pharmacy practice topics.  Mr. Kastango is the President and CEO of Clinical IQ, and can be reached as follows:

Mr. Eric S. Kastango – President and CEO
Clinical IQ, LLC 
184 Columbia Turnpike, #282 
Florham Park, NJ  07932 
Tel: (973) 765-9393 --- www.clinicaliq.com

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