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ApothéCure - Featured
Pyrogens & Sterility
ApothéCure adheres to USP 797 and 795 guidelines and utilizes a third party testing lab to measure and validate sterility, endotoxin content, and potency.
Quality Assurance Procedures
- Daily laboratory temperature/humidity monitoring.
- Daily refrigerator/freezer monitoring/calibration.
- Bi-monthly validation of autoclave.
- Daily monitoring of incubator temperatures and samples.
- Daily/weekly calibration of analytical balances.
- Chemical weight verified by printout / software.
- Independent verification of raw materials (identity, purity).
- Two-point calibration of pH meter before each use.
- Ongoing training/testing/evaluation of aseptic personnel.
- Sterility testing of every aseptic product.
- Ongoing endotoxin testing program.
- Bi-annual certification of sterile cabinet.
- Scheduled verification of sterile environment.
- Continuous cleaning of compounding environments.
- Regulated storage of raw materials and end products.
- Policy and procedure for each type of aseptic event.
- Personnel/duties policies and procedures.
- Release of patient information policies and procedures.
- Compounding software with backup for continuous record keeping of:
- Formula
- Procedure/technique
- Lot numbers
- Prescription numbers
- Expiration dates
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This includes complete recall and reporting ability on any ingredient of any product or prescription at any time.
Quality Chemicals
Quality compounding begins with quality chemicals that meet or exceed stringent pharmaceutical specifications. Inexpensive chemicals that are past or near expiration, with no independent verification, are available but unacceptable to The Compounding Pharmacy. A Certificate of Analysis is on file for ALL of our chemicals.
Selection of chemical grade: USP>NF>FCC>ASC>Stop, with distinctions made for route of administration and risk to benefit.
Our chemicals come from a FDA-inspected chemical supplier with the following quality control process:
- Upon receipt, all chemicals are visually inspected for product and container integrity, and placed into quarantine.
- The chemical’s documentation is examined for completeness and accuracy.
- A sample is taken to the quality control lab where its physical properties are compared with the certificate of analysis, United States Pharmacopoeia, British Pharmacopoeia, or other reference documents.
- Chemical identity is verified by IR spectra, UV-VIS spectra, meltpoint, specific gravity and other chemical tests.
- If the chemical meets necessary criteria, the lot number is activated and released from quarantine.
- Prior to repackaging, the bulk container’s barcode is scanned against the package labels to verify the information.
- After repackaging is complete, a random sample is pulled and identity is again confirmed.
- While filling an order, the chemical’s barcode is scanned to insure the correct chemical, size and lot number has been pulled for the corresponding order.
- A final quality control audit is performed by again scanning all barcodes to validate order completeness.
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Only one chemical supplier has this extensive quality-control program. The chemicals are more expensive, but anything less is an unnecessary risk.
Testing Protocols:
- Sterility Testing Includes (one or more of the following):
- Soybean casein digest medium (aerobic, fungal)
- Potato dextrose agar (increased fungal sensitivity)
- Fluid Thioglycollate medium (anaerobic)
- Two incubators plus room temperature
- Endotoxin Testing
- Potency Testing
- Bi-monthly surface and air quality testing of sterile isolator chamber
- Random cross check of potency and sterility by second laboratory
- Annual validation of procedures
- Semi-annual validation of personnel
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The major properties of endotoxins:
- It is a heat stable glycolipid also known as Lipid A.
- Its other properties include pyrogenicity, induce shock in hosts, lethality, tissue necrosis activity, complement activation, B cell mitogenicity in mice, immunoadjuvant activity and anti tumor activity.
Detection of Endotoxin activity:
The presence and quantitation of endotoxin can be determined by several ways. The test procedures include clot formation as well as chromogenic tests (Cape Code Inc.,) using Limulus Amebocyte Lysate (LAL) from the horse shoe crab Limulus polyphemus. LAL is an aqueous extract of blood cells (amebocytes) from Limulus polyphemus. The endotoxin test results are expressed in endotoxin units (EU) per ml and the test systems will detect as low as 0.005 EU/ml.
The biological principle of the Chromogenic test:
LAL contains enzymes that are activated in a series of reactions in the presence of endotoxin. All steps of the reactions are not fully understood. The last enzyme activated in the cascade, react with a chromogenic substrate producing an end product with an yellow color and its intensity is measured photo metrically. The end product released (color intensity) is proportional to the amount of the endotoxin present in the test system.
Important considerations in endotoxin testing:
Use aseptic techniques at all times during the test procedures
All materials used in the test procedures must be free of detectable endotoxin including the test reagents except the known endotoxin positive control.
Glassware and other heat stable materials used in the test procedures must be free of any detectable endotoxin. This can be achieved by exposure to dry heat for three hours at 180 C..
Sample for endotoxin should be collected aseptically in non-pyrogenic containers and ship frozen to the laboratory for testing. Always use depyrogenated glassware or disposable polystyrene plastic tubes are recommended to minimize adsorption of endotoxin to container surfaces. Both in Clot formation and Chromogenic testing for endotoin presence in clinical samples; it is critical to include appropriate positive and negative controls.
References:
- Guideline on validation of the Limulus Amebocyte Lysate test as an End-product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices. U S Department of Health and Human Services, Public Health Service, Food and Drug Administration, December 1987
- Bacterial Endotoxin Tests, USP 26 NF21
- Bang, F.B.1953. The toxic effect of a marine bacterium on Lumulus and the formation of blood clots. Biol.Bull.(Wood Hole, MA) 105:361-362
- Levin,J., and F.B.Bang 1964. The role of endotoxin in the extra cellular coagulation of Limulus blood. Bull. Johns Hopkins Hosp. 115: 265-274
- Progress in clinical and biological research vol.231. Detection of Bacterial Endotoxins with Limulus Amebocyte Lysate Test. 1987. Watson, S.W., J. Levin and T.J. Novitsky (Eds), Alan R. Liss, Inc., NY.
- Tsuji, K and S.J. Harrison 1978. Dry-heat destruction of lipopolysaccharide: Dry- heat destruction kinetics, Appl. Env. Microbiol. 36: 710-714
- Sweet, B.H. and J.F. Huxsoll. Depyrogenation by dry heat, Ch.12, p.101-108. in: Depyrogenation, Technical Report No.7, 1985. Parenteral Drug Association, Inc., Philadelphia, PA.
If you would like to request a specific product, or would like information on case pricing, please contact us.
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Last Modified: March 14 2012 08:02:07 |
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