trans-o-flex ambient Service overview April 2016

Transcription

1 trans-o-flex ambient Service overview April 2016

2 Requirements of current EU-GD Directive for distribution of pharmaceuticals Guidelines for Good Distribution ractices (GD) of pharmaceuticals Requirements Fulfilment by trans-o-flex 9.1 rotection of drug against breakage, impairment and theft rocess instructions, controls, cargo securing, training 9.2 Storage conditions must be complied with in transit Standard, 2 C 8 C (ThermoMed) and 15 C 25 C (trans-o-flex ambient) Deviations must be reported to the distributor and consignee Appropriate transport vehicles must be used Existence of procedural instructions for all activities Duration of interim storage should be minimised to the greatest possible extent, no detours Third parties must be contractually integrated into the GD requirements Sites of interim storage and unloading and loading require special attention regarding cleanliness, safety and temperature monitoring 9.3 Appropriate protection by selecting suitable packagings and containers 9.4 Equipment for temperature monitoring must be maintained and calibrated rocedural instructions for emergency deliveries Special products make a protected supply chain (national law) and special control systems necessary Communication of deviations pursuant to agreements Qualified vehicles, vehicle fleet policy, process instructions SO s, driver portfolio Handling and further loading on a daily basis after takeover of goods, Standard delivery by the next business day (Monday to Friday), automatic return in line with a fixed time window in the absence of consignor instruction Service provider agreements, freight carrier agreements, quality assurance agreements Cleaning procedure, access regulation, video monitoring, perimeter fence, transponder, etc. ThermoMed / trans-o-flex ambient: continuous temperature monitoring Jurisdiction of manufacturer / client ThermoMed / trans-o-flex ambient SO s and maintenance overviews, calibration protocols, etc. Jurisdiction of wholesalers Special processes for radio-pharmaceuticals Special feedback regulation for breakage of BTM 2

3 trans-o-flex ambient harmaceutical distribution at 15 C to 25 C Schnell-Lieferdienst Standard (non-temperature-controlled) ThermoMed 2 C 8 C 15 C 25 C 15 C 25 C trans-o-flex ambient With trans-o-flex ambient, pharmaceutical products are transported temperature-controlled and documented from pick-up through to delivery in the range of 15 C to 25 C. 3

4 Delivery structure of trans-o-flex ambient Small items Large items 100% actively temperaturecontrolled delivery vehicles 12 t Actively temperaturecontrolled 12 t trucks for delivery of pallets Transporter with actively temperaturecontrolled thermos box for joint delivery of standard and ambient goods 40 t Actively temperaturecontrolled 40 t trucks for regular service and largescale delivery (e.g. wholesale) 4

5 Temperature alarm control with trans-o-flex ambient C IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII xM* 7xM* 7xM* 1xM* Regular range Tolerance range Critical range No action Delivery stop with seventh interval measurement in a row Delivery stop with first interval measurement * Measuring interval: - 15 min. integral measurement 5

6 Scope of trans-o-flex ambient services ermissible package dimensions and weights Optional add-on services of trans-o-flex ambient arcel Max. parcel dimension: L 60 x W 40 x H 40 cm Max. weight: 25 kg allet Max. pallet height: 160 cm (overall size) Max. weight: 500 kg Basic measures: europallet trans-o-flex Avis trans-o-flex Cash-on-delivery Service trans-o-flex Confidential Service trans-o-flex co2de green trans-o-flex Evening Service ¹ trans-o-flex Hazardous Goods (except class 1 & 7) trans-o-flex HomeCare trans-o-flex Island Service ¹ trans-o-flex medipack trans-o-flex plus 12:00 noon trans-o-flex remium Delivery for Bulk Customers trans-o-flex Saturday Service trans-o-flex Time-definite Service International transports / EUROTEM ¹ ¹ by arrangement 6

7 Advantages of trans-o-flex ambient at a glance Qualitative Advantages Actively temperature-controlled delivery of ambient goods Germany-wide Continuous temperature documentation Auditable quality management system Trained drivers Central temperature monitoring Scanning of each change of room Security by marking the package with transo-flex ambient label Standard delivery by the next business day (Monday to Friday) Extended scope of service Delivery from one single source: standard and ambient goods in one delivery Hazardous goods-compatible allet-compatible Cost advantages: No additional temperature measuring equipment Operative Advantages Use of standard packagings Easy handling for order picking Advantages of the trans-o-flex Logistics Group One sales contact person One customer service One data transfer One track & trace system One invoicing system 7

8 trans-o-flex Logistics Group Hertzstraße Weinheim Germany