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USP Regulation 797 for sterile compounding

Issued by the non-pro t US Pharmacopoeia (USP) and endorsed by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), “USP Regulation 797” is the rst enforceable standard for sterile compounding. Originally enacted on January 1, 2004, the latest version became of cial on June 1, 2008. “USP 797” is a broad regulation that covers a variety of pharmacy policies and procedures. It is designed to reduce the number of patient infections due to contaminated pharmaceutical preparations.

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125 TRIO.BAS Air Sampler - Care, Maintenance, Battery Charging

124 Cleanroom Microbial Air Monitoring with Operative Efficiency by TRIO.BAS Air Sampler

123 Indoor Air Bioaerosol Sampling from Building according NIOSH

122 Microbial Air Monitoring suggestions for reference graphic preparation

121 Evaluation of Microbial Contamination in Hospital, Clinic, Health Care Premises, etc

120 Correrct use of reference graphic in trends for Microbiological Environmental Data (MED)

119 Expulsion of Droplets during a Sneeze

118 TRIO.BAS Aspiration Cycle “Multimode”

117 Airborne Bacteria, Viruses and Spores in poultry premises by High Efficiency Electrostatic Bacterial Air Sampler

116 MUSEUM OF MICROBIAL AIR SAMPLERS Villa Cella – Milan

115 Protocol of Dressing in Cleanroom

114 The Gamma Irradiation

113 Do’s and Dont’ts in aseptic practices

112 Use of “Daily Shift” Sterile Aspirating Head for TRIO.BAS Air Samplers in Cleanroom

111 Applied microbiology in Cleanroom

110 Test questions related to working activity in Clean Room

109 Agar moisture loss in Petri dish using an impact air sampler system

108 The correct use of the I.Q., O.Q., P.Q. Qualification Manuals

107 SOP (Standard Operating Procedure) for TRIO.BAS ISOLATOR Microbial Air Sampler

106 Suggested procedures for microbial air sampling

105 Microbial Air sampler positioning

104 Data Integrity Good Practice in Microbial Environmental Monitoring

103 The TRIO.BAS C-D microbial air sampler to be used with Compact-Dry plates

102 Evaluation of two microbial active air samplers

101 The “physical laws” that regulate the diffusion and deposition of particles in the air

100 The physical tests to obtain the safety certifications of TRIO.BAS

99 Microbial Air Sampling Collection Efficiency – The number of Stokes

98 The Micro-Organisms in the Air

97 News in TRIO.BAS Sampler Software and Hardware

96 Subdivision of hospital operating department in different areas depending on the biological risk for staff and patients

95 Muestreador microbiológico de aire TRIO.BAS TRIO para la detección de contaminación microbiana en salas limpias y entornos controlados.

94 Instruction for Daily Shift Aspirating Head

93 The difference between D.Q., I.Q., O.Q., P.Q.

92 The considerations in selecting an aspirating head for active air samplers

91 Standard Operating Procedure for TRIO.BAS ISOLATOR

90 The interval time programmed air sampling in isolator and RABS by TRIO.BAS DUO and TRIO

89 TRIO.BAS ISOLATOR microbial air sampler technical details

88 Useful information about Pharmaceutical Environmental Microbiology

87 Useful information about Pharmaceutical Environmental Microbiology

86 Indoor air filtration system microbial monitoring

85 Compressed gas in pharma facilities. Microbial monitoring

84 USP 1116 for Microbial Air Monitoring – OOS (Out Of Specifications) and OOT (Out Of Trends)

83 TRIO.BAS MINI BLUETOOTH Microbial air sampler – Barcode Brief instructions

82 Sampling viable organisms by microbial active air samplers

81 The Bluetooth applications to transfer data from the TRIO.BAS microbiological air sampler

80 Glossary according USP 38

79 Culture medium and diluent USP 38

78 Microbial isolates identification accordingUSP 38

77 Isolators, glove boxes, RABS, C-RABS: what are they and what are the differences?

76 SOP – Standard Operating Procedure for use, maintenance, calibration of “TRIO.BAS” microbiological air samplers

75 Sequential sampling

74 Routine monitoring of air quality required in areas used for compounding sterile preparations

73 Air sampler disinfection

72 The choise and use of an active Microbial Air Sampler

71 TRIO.BAS GAS Microbial content in compressed air and gas – SOP Document

70 Test of spontaneous generation

69 TRIO.BAS Air Sampler Biological ef ciency test according ISO 14698-1

68 The ideal m/s speed of the impact air on agar surface of active air sampler

67 Air sampling in food premises

66 Air sampling in Hospital

65 Microbial air monitoring in Isolators

64 Full traceability

63 Good Air Monitoring Practice

62 Position of samplers in Cleanroom

61 Choose and comparation of samplers

60 Microrganism stress

59 Hole impact distribution

58 Fumigation

57 SOP Microbial Compressed Air/Gas Sampling according ISO 8573-7

56 Microbial Air Sampler with different air flow rate performances comparison

55 TRIO.BAS MINI Microbial Air Sampler Brief Illustrated Instructions

54 Application of MPN in microbial air environmental tests

53 The Barcode application in microbial environmental monitoring

52 Short course of microbiology for environmentalist

51 Training of personnel in Cleanroom, Isolator, RABS according USP 38 – The United States Pharmacopeial – Document (1116) Aseptic Processing Environments – Page 1195

50 Ten suggestions to apply the Best Micro-Pipette Practice in microbiology

49 Simple tips to facilitate the phenotypic identification of aerobic microorganisms after collection and incubation in Petri dish.

48 The Bluetooth applications to transfer data from the TRIO.BAS microbiological air sampler.

47 Glossary for Microbiological Air Environmental Monitoring

46 Culture media and diluents – Selection of Growth Media in Cleanrooms, RABS, Isolator